Feasibility of Exercise and Transcranial Direct Current Stimulation for the Treatment of Post-traumatic Headache
Headaches Posttraumatic · Neck Pain
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 1
- Age range
- 18 years - 60 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 18 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The goal of this prospective case series is to assess the feasibility of intervention and assessment protocols for telehealth intervention with mindfulness-based exercise, transcranial direct current stimulation, and their combination in Veterans with peristent post-traumatic headache. The main questions it aims to answer are:
What percentage of patients complete pre- and post- assessment measures? Are patients adherent to and satisfied with each intervention? What are potential adverse effects of treatment? How responsive are patient-reported outcome measures and biomarkers of brain connectivity, muscle health, and pain sensitivity to change following treatment?
Participants will complete 18 telehealth sessions with a physical therapist (3x/wk for 6 weeks) with one of the following interventions:
1. mindfulness-based cervicoscapular exercise
2. transcranial direct current stimulation (tDCS) over the motor cortex
3. combined treatment with exercise and tDCS
Participants will complete the following assessments before and after intervention:
1. magnetic resonance imaging (MRI) of the brain
2. MRI of neck muscles
3. quantitative sensory testing of pain sensitivity
4. health questionnaires
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Veterans aged 18-60 years
- Persistent post-traumatic headache defined as new or worsening headache within 12 months of a mild or moderate traumatic brain injury with ongoing persistent symptoms interferring with activities of daily living for 3 or more months
- Grade II interferring neck pain with ongoing persistent symptoms for the past 3 or more months in a single episode or across multiple episodes
Exclusion Criteria:
- acute injury within the previous 3 months resulting in moderate to severe pain
- head or neck pathology such as fracture, tumor, or infection
- systemic disease or neurological involvement other than pain resulting in moderate to severe impairments in sensory or motor function (e.g., lupus, diabetic neuropathy, spinal cord injury)
- history of moderate to severe headache or neck pain prior to first-identified traumatic brain injury
- lifetime diagnosis of bipolar or psychotic disorder, or current substance use disorder with a positive urine drug test within 30 days of study participation, as documented in the medical record
- suicidal or homicidal ideation
- standard contraindication for MRI or tDCS
- pregnant or lactating, to avoid confounding effects of hormone fluctuations
- current widespread pain of greater than moderate intensity, as indicated by pain in 4 or more locations on the McGill Pain Diagram
- contraindications for the cold pressor task, including uncontrolled cardiovascular disorders (high blood pressure, heart disease, or dysrhythmia), fainting easily (vasovagal syncope), frostbite on arm, history of Reynaud's, or open cut, sore, or bone fracture on the limb to be immersed in water
- use of opioids or other narcotic analgesics within the previous 3 months
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Mindfulness-based cervicoscapular exercise (CSE)
Progressive resistance exercise program to improve motor control, strength, and endurance of craniocervical and scapular muscles performed with guided mindfulness instruction
Behavioral: Exercise
Transcranial direct current stimulation (tDCS) of the motor cortex
Anodal stimulation applied over the left primary motor cortex for 20 minutes at 2 mA
Device: transcranial direct current stimulation
Combined CSE and tDCS
CSE performed concurrently with tDCS
Behavioral: Exercise · Device: transcranial direct current stimulation
Exercise BEHAVIORAL
30-min supervised (via telehealth) progressive resistance exercise program performed with guided mindfulness. Cervicoscapular exercises include: warm up/flexibility, craniocervical flexion, craniocervical extension, scapular protraction, scapular retraction.
transcranial direct current stimulation DEVICE
20 minutes of supervised (via telehealth) direct current anodal stimulation over the left primary motor cortex with cathodal stimulation over the right prefrontal cortex at 2 mA
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Participant retention
Time frame: From enrollment to the post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Percent of enrolled participants who complete the post-intervention assessment for each treatment arm as measured by assessment attendance logs in REDCap
Treatment adherence
Time frame: From first to last treatment session completed (18 sessions, ~6-weeks)
Percent of prescribed treatment sessions completed by participants who are retained in each treatment arm as measured by treatment attendance logs in REDCap
Treatment satisfaction
Time frame: From first treatment session to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Median Global Rating of Perceived Satisfaction for each treatment arm (reverse-scored range: 1 "extremely dissatisfied" to 7 "extremely satisfied")
Secondary measures
Treatment duration
Time frame: From first to last treatment session completed (~ 6 weeks)
Average number of weeks required to complete 18 prescribed treatment sessions for participants retained in each treatment arm as measured by treatment attendance logs in REDCap
Perceived improvement
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Median Global Rating of Perceived Improvement for each treatment arm (reverse-scored range: 1 "very much worse" to 7 "very much improved")
PROMIS headache intensity, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Pain Intensity v2.0 T-score for headache, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
PROMIS neck pain intensity, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Pain Intensity v2.0 T-score for neck pain, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Headache Impact Test-6, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in Short-Form Headache Impact Test-6 score, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Neck Pain and Disability Scale, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in Neck Pain and Disability Scale score, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Obliquus Capitis Inferior
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Rectus Capitis Posterior Major
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Rectus Capitis Posterior Minor
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Longus Colli/Capitis C2/3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Longus Colli/Capitis C5/6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Sternocleidomastoid C2/3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Sternocleidomastoid C5/6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Multifidi C3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Fraction, Multifidi C6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Obliquus Capitis Inferior
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Rectus Capitis Posterior Major
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Rectus Capitis Posterior Minor
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Longus Colli/Capitis C2/3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Longus Colli/Capitis C5/6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Sternocleidomastoid C2/3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Sternocleidomastoid C5/6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Multifidi C3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Total Muscle Volume, Multifidi C6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Obliquus Capitis Inferior
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Rectus Capitis Posterior Major
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Rectus Capitis Posterior Minor
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Longus Colli/Capitis C2/3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Longus Colli/Capitis C5/6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Sternocleidomastoid C2/3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Sternocleidomastoid C5/6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Multifidi C3
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Fat Free Muscle Volume, Multifidi C6
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-Cerebellum (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and cerebellum (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-Cerebellum (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and cerebellum (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-DLPFC (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and dorsolateral prefrontal cortex (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-DLPFC (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and dorsolateral prefrontal cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-M1 (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary motor cortex (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-M1 (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary motor cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-S1 (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary sensory cortex (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-S1 (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary sensory cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-SMA (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and supplementary motor area (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-SMA (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and supplementary motor area (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-Thalamus (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and thalamus (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-Thalamus (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and thalamus (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-TPJ (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and temporoparietal junction (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-TPJ (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and temporoparietal junction (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-MCC (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and middle cingulate cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Resting State Functional Connectivity, PAG-PCC (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and posterior cingulate cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Trapezius (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the trapezius muscle (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Trapezius (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the trapezius muscle (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Temporalis (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the temporalis muscle (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Temporalis (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the temporalis muscle (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Frontalis (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the frontalis muscle (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Frontalis (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the frontalis muscle (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Neck (left)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the C3 spinous process (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Neck (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the C3 spinous process (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Pressure Pain Threshold, Forearm (right)
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the forearm flexor muscles (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Other measures
PROMIS Anxiety, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Anxiety Short Form 8a T-score for severity of anxiety symptoms, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
PROMIS Depression, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Depression Short Form 8a T-score for severity of depressive symptoms, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
PCL-5, measurement responsiveness
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Within-group effect size (Hedge's g) for pre-post intervention change in Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 score for severity of PTSD symptoms, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
VA San Diego Healthcare SystemSan Diego, California, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- San Diego State University
- Study start
- Jul 1, 2021 Actual
- Primary completion
- Oct 14, 2022 Actual
- Study completion
- Oct 14, 2022 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Imaging Markers of Central and Peripheral Impairment in Chronic Post-Traumatic Headache
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026