Recruiting

Phase 2

TMSPersonalized Brain Stimulation to Treat Chronic Concussive Symptoms

Sponsor:

UCLA

Code:

NCT06073886

Conditions

Post-Concussion Syndrome

Concussion, Brain

Mild Traumatic Brain Injury

Head Injury

Headache

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active cTBS

Inactive/Sham cTBS

Imaginal exposure

Study Details

Brief 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.

Conditions

Post-Concussion Syndrome

Concussion, Brain

Mild Traumatic Brain Injury

Head Injury

Headache

Study ID

NCT06073886

Start date

Mar 6, 2024

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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)
severe mental, physical, or medical problems that would impede participation or pose a risk for the planned intervention (e.g., liver, kidney, or heart disease, uncontrolled diabetes or hypertension, malignancy, psychosis, previous seizure, pregnancy)
active alcohol or illicit drug abuse
inability to speak and read English

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Active 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.

Inactive/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.

Imaginal exposure

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

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 ]
Peripheral 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 ]
Persistent post-concussive symptoms modulation and durability [ Time Frame: Change from baseline across all subsequent time points until completion of the study, an average of 4 months ]
Fear avoidance 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 and Locations

Central contacts

Kevin Bickart, MD/PhD

(818)392-4614 bickartlab@gmail.com

Locations

UCLA

Recruiting

Westwood, Los Angeles, California, United States, 90095

Principal Investigator:

Kevin Bickart, MD/PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Keywords

Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Functional MRI
Personalized neuromodulation
Amygdala
Prefrontal Cortex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-24.