RecruitingNCT06848140ClinicalTrials.gov record

Using Non-invasive Brain Stimulation to Treat Word Finding Difficulty in Chronic Traumatic Brain Injury

Traumatic Brain Injury · Word Finding Difficulty · Cognitive Symptom · Cognitive Change · Acquired Brain Injury

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THE QUICK READ

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 - 85 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 14 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of this study is to learn more about how brain stimulation affects word finding problems in people who have a traumatic brain injury (TBI). The type of brain stimulation used is called transcranial direct current stimulation (tDCS). tDCS delivers low levels of electric current to the brain and high definition tDCS (HD-tDCS) delivers the current with multiple electrodes on the scalp. This current is delivered with HD-tDCS to parts of the brain that may help with remembering things. The investigators hope that this can help to improve word finding and memory problems in people with TBI.

Read the full description

The investigators plan to recruit English-speaking participants aged 18-85 years with a history of chronic TBI (\> 1 year since injury prior to enrollment), all of whom have problems with cognition. The participants will be randomized to receive (1) active first followed by sham HD-tDCS condition, or (2) sham first followed by active condition in order to assess the efficacy of HD-tDCS on improving verbal retrieval function. The randomization will be double-blinded to the participants and the research personnel who administer the procedures. The study therefore adopts a double-blind randomized cross-over design. The proposed study will measure response to HD-tDCS treatment over the pre-supplementary motor area (preSMA) region when compared to sham with verbal retrieval function (verbal fluency, naming, verbal learning) as the primary outcome. Secondary outcome measures include cognitive performance other than verbal retrieval function and electroencephalography (EEG) measures. The participants will receive two phases of 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA for 20 min) or sham across 2 weeks. All participants will be blinded to their condition. EEG and neuropsychological tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. The participants will also undergo an MRI session at baseline. Those participants randomized into the active or sham group will have the opportunity to return after 2 months and receive sham (if active first) or active (if sham first) treatment and will undergo the EEG and neuropsychological tests again immediately following the last HD-tDCS session and at a 2-month follow-up.

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:

Age between 18 and 85
Fluent in speaking and reading English
Able to provide informed consent
Has a TBI at least one year prior to enrollment and not related to military experience
Has a confirmation of verbal retrieval difficulties as measured by the Verbal Retrieval Difficulty Interview questions

Exclusion Criteria:

Lifetime major or active neurologic conditions (e.g., stroke, epilepsy, brain tumor, dementia, seizure occurrence less than one year ago)
Lifetime major or active cardiovascular conditions (e.g., cardiac arrythmia, heart failure, heart attack)
Current substance use disorder
Lifetime major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
Severe depression at the time of enrollment (BDI-II \>= 29) or psychiatric ER visits or hospitalization less than 6 months ago prior to enrollment
Current sensory (e.g., blind, deaf) or physical (e.g., severe motor weakness) impairment that interferes with testing
Contraindications for tDCS or MRI
The person cannot be left alone for 8+ hours.
Not verbally communicative.
Currently undergoing and not wishing to discontinue speech and cognitive therapy during study participation.
Incapable of understanding the consent or unable to consent for oneself.
Unable to travel to BIDMC's Berenson-Allen Center
Pregnancy

Understand screening

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: Random assignment
Masking: Triple masked

Active to Sham Transcranial direct current stimulation

Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.

Device: Active Transcranial direct current stimulation · Device: Sham Transcranial direct current stimulation

Sham to Active transcranial direct current stimulation

Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.

Device: Active Transcranial direct current stimulation · Device: Sham Transcranial direct current stimulation

Active Transcranial direct current stimulation DEVICE

Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.

Sham Transcranial direct current stimulation DEVICE

Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

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