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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCLA
RECRUITING
Westwood, Los Angeles
Contact Information
Primary
Kevin Bickart, MD/PhD
bickartlab@gmail.com
(818)392-4614
Time Frame
Start Date: 2024-03-06
Estimated Completion Date: 2027-01
Participants
Target number of participants: 75
Treatments
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.
Sponsors
Collaborators: United States Department of Defense
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov