NCT06073886 Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
| NCT ID | NCT06073886 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Post-Concussion Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2024-03-06 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.
Eligibility Criteria
Inclusion Criteria: * Mild traumatic brain injury (mTBI) defined in accord with the World Health Organization criteria in the last 12 months * age 18-65 at the time of the mTBI * high burden of post-concussive symptoms defined as a score \>=20 on the Rivermead Post-Concussion Symptoms Questionnaire Exclusion Criteria: * objective neurologic deficits * ongoing or prolonged (\>3 months) post-concussive symptoms from a prior mTBI within 2 years of the index injury * history of transcranial magnetic stimulation (TMS) therapy * contraindications for TMS or magnetic resonance imaging (MRI) (e.g., metallic implant other than dental, pacemaker) * severe mental, physical, or medical problems that would impede participation or pose a risk for the planned intervention (e.g., liver, kidney, or heart disease, uncontrolled diabetes or hypertension, malignancy, psychosis, previous seizure, pregnancy) * active alcohol or illicit drug abuse * inability to speak and read English
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06073886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post-Concussion Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06073886 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06073886 currently recruiting?
Yes, NCT06073886 is actively recruiting participants. Contact the research team at bickartlab@gmail.com for enrollment information.
Where is the NCT06073886 trial being conducted?
This trial is being conducted at Westwood, Los Angeles, United States.
Who is sponsoring the NCT06073886 clinical trial?
NCT06073886 is sponsored by University of California, Los Angeles. The trial plans to enroll 75 participants.