RecruitingPhase 2NCT06073886

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Personalized Circuit-Based Frontoamygdala Neuromodulation for Persistent Post-Concussive Symptoms


Sponsor

University of California, Los Angeles

Enrollment

75 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests personalized brain stimulation (using a technique called TMS — transcranial magnetic stimulation) to treat persistent symptoms after a mild traumatic brain injury (concussion). Many people continue to experience headaches, brain fog, sleep problems, and mood changes for months after a concussion, and this study tests whether targeted brain stimulation can help. **You may be eligible if...** - You have had a mild traumatic brain injury (concussion) within the last 12 months - You were between 18 and 65 at the time of your injury - You have a high burden of ongoing post-concussion symptoms (score ≥ 20 on the Rivermead questionnaire) **You may NOT be eligible if...** - You have objective neurological deficits on examination - You have had prolonged symptoms from a prior concussion within the last 2 years - You have a history of TMS therapy - You have a pacemaker, metal implant in your skull, or other contraindications to TMS or MRI - You have severe psychiatric or medical problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive cTBS

600 active cTBS pulses will be delivered continuously (3 pulses at 50 hertz (Hz), repeated at 5 Hz, 15 pulses/sec, continuously for 40 seconds) twice/day for 1,200 pulses/day. The MagVenture MagPro active/sham system will be used to enable double blinding by universal serial bus (USB) key in which a current will be delivered through surface electrodes on the skin beneath the coil to mimic the sensory experience of cTBS for active and sham groups.

DEVICEInactive/Sham cTBS

600 inactive, or sham, cTBS pulses will be delivered continuously (3 pulses at 50 hertz (Hz), repeated at 5 Hz, 15 pulses/sec, continuously for 40 seconds) twice/day for 1,200 pulses/day. The MagVenture MagPro active/sham system will be used to enable double blinding by universal serial bus (USB) key in which a current will be delivered through surface electrodes on the skin beneath the coil to mimic the sensory experience of cTBS for active and sham groups.

BEHAVIORALImaginal exposure

Personalized recordings about participants' descriptions of triggering or neutral stimuli or activities


Locations(1)

UCLA

Westwood, Los Angeles, California, United States

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NCT06073886


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