Frontoamygdala hyperconnectivity predicts affective dysregulation in adolescent moderate-severe TBI.
Kevin C Bickart, Alexander Olsen, Emily L Dennis...
https://pubmed.ncbi.nlm.nih.gov/36684686Actively Recruiting
Led by University of California, Los Angeles · Updated on 2026-02-24
75
Participants Needed
1
Research Sites
26 weeks
Total Duration
U
University of California, Los Angeles
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
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
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
Total: 1 location
1
UCLA
Westwood, Los Angeles, California, United States, 90095
Actively Recruiting
K
Kevin Bickart, MD/PhD
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