LIFU for Chronic Pain and Generalized Anxiety Disorder
Chronic Pain · Generalized Anxiety Disorder
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 65 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 10 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.
Read the full description
A single-arm, open label, 2 cohort (chronic pain/GAD) case study with extended (6 months) follow-up following accelerated low-intensity focused ultrasound for neuromodulation.
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:
- GAD Symptoms - GAD-7 score \>= 10, OASIS score \>= 8, or PSWQ score \>= 45. OR Chronic pain symptoms - moderate to severe pain, present for at least 3 months.
Exclusion Criteria:
- Claustrophobia
- Contraindications to MRI or CT
- Active medical disorder with CNS effects
- History of neurologic disorder
- History of head injury with LOC \> 10 minutes
- Active drug or alcohol dependence
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 applicable
- Masking
- No masking
Low-intensity focused ultrasound for neuromodulation
Accelerated (repeat) LIFU application for neuromodulation
Device: Low Intensity Focused Ultrasound
Low Intensity Focused Ultrasound DEVICE
Low-Intensity Focused Ultrasound applied multiple times in a single study visit.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Safety - monitoring of possible symptoms
Time frame: Throughout study participation at multiple time points, approximately 6 months.
Symptom monitoring before and after LIFU applications and throughout 6 months of follow-up. Each symptom is presented with a likert scale (absent, mild, moderate, severe) - along with a free response option for any symptoms not included in the list.
Changes in Chronic Pain - self report
Time frame: Multiple timepoints throughout the 6 month experimental timeframe.
Participants will complete the Brief Pain Inventory (BPI) at multiple time points throughout the 6 month period. This questionnaire asks participants to rate their pain on a 10 point scale (10 being the most pain).
Changes in Anxiety - self report
Time frame: Throughout the experimental timeframe, approximately 6 months.
Participants will complete the Beck Anxiety Inventory (BAI) at multiple time points before and after LIFU application to track changes in anxiety throughout the 6 month timeframe. The BAI probes different symptoms of anxiety and participants rate it on a likert scale (not at all, mildly, moderately, or severely).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Fralin Biomedical Research Institute at VTCRoanoke, Virginia, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Study start
- 2026-12 Estimated
- Primary completion
- 2027-08 Estimated
- Study completion
- 2027-12 Estimated
- First posted
- Jul 7, 2026 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
Official study title
Accelerated Low-Intensity Focused Ultrasound (LIFU) for Chronic Pain and Generalized Anxiety Disorder: A Proof-of-Concept Case Series
Ask Wellness Clinical Research
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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 9, 2026