Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Part of paid clinical trials in Westwood, Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06073886
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active cTBS — DEVICE
    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.
  • Inactive/Sham cTBS — DEVICE
    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.
  • Imaginal exposure — BEHAVIORAL
    Personalized recordings about participants' descriptions of triggering or neutral stimuli or activities

Study Details

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.

Key Dates

Start date
Mar 6, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active continuous theta-burst stimulation (cTBS) plus exposure
    10 days of active, continuous theta-burst stimulation (cTBS) will be delivered to a personalized region of the ventromedial prefrontal cortex (vmPFC) based on baseline brain circuit mapping for each individual participant.
  • Sham Comparator: Inactive/Sham continuous theta-burst stimulation (cTBS) plus exposure
    10 days of inactive, or sham, continuous theta-burst stimulation (cTBS) will be delivered to a personalized region of the ventromedial prefrontal cortex (vmPFC) based on baseline brain circuit mapping for each individual participant.
  • Active Comparator: Active Comparator continuous theta-burst stimulation (cTBS) plus exposure
    10 days of active, continuous theta-burst stimulation (cTBS) will be delivered to a personalized region of the ventromedial prefrontal cortex (vmPFC) based on baseline brain circuit mapping for each individual participant.

Primary Outcome Measure

Central target engagement, modulation, and durability [ Time Frame: Change from baseline across all subsequent time points until completion of the study, an average of 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLAWestwood, Los AngelesCalifornia90095
Kevin Bickart, MD/PhD
Kevin Bickart, MD/PhD (PRINCIPAL_INVESTIGATOR)

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