Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06073886

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

Led by University of California, Los Angeles · Updated on 2026-02-24

75

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a new personalized brain stimulation treatment called transcranial magnetic stimulation (TMS) for people aged 18 to 65 who have chronic symptoms following a concussion or mild traumatic brain injury. These symptoms include dizziness, headache, fatigue, brain fog, memory issues, sleep problems, irritability, and anxiety, which can interfere with daily life and work. The study aims to see if personalized TMS can improve brain connectivity, reduce avoidance behaviors and symptoms, and whether these improvements last up to two months after treatment. It also seeks to identify who may respond best to this treatment. Participants will be randomly assigned to receive either active or sham (inactive) continuous theta-burst stimulation (cTBS) targeted to a personalized region of the ventromedial prefrontal cortex, based on individual brain circuit mapping. The treatment consists of 10 days of cTBS sessions. The active treatment delivers pulses designed to modulate brain activity, while the sham treatment mimics the sensation without actual stimulation. Both groups also engage in imaginal exposure using personalized recordings of triggering or neutral stimuli. Participants will attend 14 visits including baseline assessments and MRI scans, 10 treatment sessions, and 3 post-treatment follow-ups with symptom evaluations and MRIs. The study measures changes in brain circuit activity, post-concussive symptoms, fear avoidance behaviors, sleep quality, and heart rate variability over an average of 4 months. Safety and treatment effects will be carefully monitored throughout the study period.

CONDITIONS

Brief Title

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mild traumatic brain injury (mTBI) within the last 12 months defined by World Health Organization criteria
  • Age between 18 and 65 years at time of mTBI
  • High burden of post-concussive symptoms with a score of 20 or higher on the Rivermead Post-Concussion Symptoms Questionnaire
Not Eligible

You will not qualify if you...

  • Presence of objective neurologic deficits
  • Ongoing or prolonged post-concussive symptoms lasting more than 3 months from a prior mTBI within 2 years of the current injury
  • Prior transcranial magnetic stimulation (TMS) therapy
  • Contraindications to TMS or MRI, such as metallic implants other than dental or pacemaker
  • Severe mental, physical, or medical conditions that could interfere with participation or pose risk, including liver, kidney, heart disease, uncontrolled diabetes or hypertension, malignancy, psychosis, previous seizures, or pregnancy
  • Active alcohol or illicit drug abuse
  • Inability to speak and read English

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 10 days

Participants receive personalized continuous theta-burst stimulation (cTBS) targeting a specific brain region based on individual brain circuit mapping, combined with imaginal exposure therapy to address chronic concussive symptoms.

Daily visits for 10 days

Follow-up

Duration - Up to 4 months after treatment

Participants are monitored for changes in brain circuit activity, post-concussive symptoms, and related behavioral measures after treatment completion.

Periodic follow-up visits up to 4 months

Trial Site Locations

Total: 1 location

1

UCLA

Westwood, Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

K

Kevin Bickart, MD/PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial