Frontoamygdala hyperconnectivity predicts affective dysregulation in adolescent moderate-severe TBI.
Kevin C Bickart, Alexander Olsen, Emily L Dennis...
https://pubmed.ncbi.nlm.nih.gov/36684686/Actively Recruiting
Led by University of California, Los Angeles · Updated on 2026-02-24
75
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are studying a new personalized brain stimulation treatment called transcranial magnetic stimulation TMS for people aged 18 to 65 who have chronic symptoms following a concussion or mild traumatic brain injury. These symptoms include dizziness, headache, fatigue, brain fog, memory issues, sleep problems, irritability, and anxiety, which can interfere with daily life and work. The study aims to see if personalized TMS can improve brain connectivity, reduce avoidance behaviors and symptoms, and whether these improvements last up to two months after treatment. It also seeks to identify who may respond best to this treatment. Participants will be randomly assigned to receive either active or sham inactive continuous theta-burst stimulation cTBS targeted to a personalized region of the ventromedial prefrontal cortex, based on individual brain circuit mapping. The treatment consists of 10 days of cTBS sessions. The active treatment delivers pulses designed to modulate brain activity, while the sham treatment mimics the sensation without actual stimulation. Both groups also engage in imaginal exposure using personalized recordings of triggering or neutral stimuli. Participants will attend 14 visits including baseline assessments and MRI scans, 10 treatment sessions, and 3 post-treatment follow-ups with symptom evaluations and MRIs. The study measures changes in brain circuit activity, post-concussive symptoms, fear avoidance behaviors, sleep quality, and heart rate variability over an average of 4 months. Safety and treatment effects will be carefully monitored throughout the study period.
CONDITIONS
Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
K
Kevin Bickart, MD/PhD
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University of California, Los Angeles
Lead Sponsor
United States Department of Defense
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Active cTBS + exposure | Sham cTBS + exposure |
|---|---|---|
| What it is | A personalized, noninvasive brain stimulation treatment using active continuous theta-burst stimulation (cTBS) delivered with a double-blinded device, combined with personalized imaginal exposure exercises. | A procedure using inactive (sham) continuous theta-burst stimulation designed to mimic the experience of the device, combined with the same personalized imaginal exposure exercises. |
| Role in the study | Investigational arm testing whether active cTBS plus exposure improves post-concussion symptoms compared to sham. | Comparator arm receiving sham stimulation to match the active treatment protocol, controlling for non-specific effects. |
| Primary use or intended effect | To evaluate whether active personalized cTBS targeting brain function combined with exposure exercises reduces persistent symptoms in adults following mild traumatic brain injury. | To measure outcomes in participants who receive exposure alone plus a sham procedure, serving to distinguish true treatment effects from placebo effects. |
| How it is given or performed | Active cTBS is delivered using a device that applies magnetic pulses to the scalp, twice daily, totaling 1,200 pulses per day. This is paired with imaginal exposure sessions customized to individual triggers. | Participants undergo procedures identical to the active group, but the device is set to deliver sham stimulation without active magnetic pulses, while still receiving exposure sessions. |
| Evidence status | Currently under clinical investigation. Results for use in post-concussive symptoms and the strength of clinical evidence are not yet established. | Serves as a control arm to measure effects due to placebo and non-specific components. No therapeutic effects are expected from sham stimulation. |
| Important limitations | This is a double-blind trial, so neither participants nor clinicians know who receives real or sham stimulation. The benefits and risks for cTBS in this application are not yet known, and there are eligibility exclusions based on medical risks. | Serves strictly as a research control and does not provide therapeutic stimulation. The blinding and exclusion criteria apply as in the investigational arm. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 10 days
Participants receive personalized continuous theta-burst stimulation (cTBS) targeting a specific brain region based on individual brain circuit mapping, combined with imaginal exposure therapy to address chronic concussive symptoms.
Daily visits for 10 days
Duration - Up to 4 months after treatment
Participants are monitored for changes in brain circuit activity, post-concussive symptoms, and related behavioral measures after treatment completion.
Periodic follow-up visits up to 4 months
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Kevin C Bickart, Alexander Olsen, Emily L Dennis...
https://pubmed.ncbi.nlm.nih.gov/36684686/University of California, Los Angeles
Lead Sponsor
United States Department of Defense
Collaborating Sponsor