Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Los Angeles

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Active cTBS
  • Inactive/Sham cTBS
  • Imaginal exposure

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

United States Department of Defense

Collaborator