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Procedure

Brain Stimulation for Post-Concussion Syndrome

Phase 2

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High burden of post-concussive symptoms defined as a score >=20 on the Rivermead Post-Concussion Symptoms Questionnaire

Age 18-65 at the time of the mTBI

Must not have

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)

Objective neurologic deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline across all subsequent time points until completion of the study, an average of 4 months

Summary

This trial tests a noninvasive brain stimulation therapy to improve chronic symptoms of concussion or mild traumatic brain injury.

Who is the study for?

This trial is for people aged 18-65 who've had a mild traumatic brain injury in the last year and are struggling with symptoms like dizziness, headaches, or memory issues. They should have significant post-concussive symptoms but no severe medical conditions, drug abuse history, previous TMS therapy, or MRI contraindications like pacemakers.

What is being tested?

The study tests personalized transcranial magnetic stimulation (TMS) to treat chronic concussion symptoms. Participants will visit UCLA for baseline assessments and MRIs, receive TMS over ten sessions, and then have follow-up assessments. Two-thirds will get active TMS believed to change brain function; one-third will get sham TMS.

What are the potential side effects?

While not specified here, common side effects of TMS may include headache or scalp discomfort at the treatment site during active stimulation. There's also a small risk of seizure with this type of brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I score 20 or more on the Rivermead Post-Concussion Symptoms test.

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I was between 18 and 65 years old when I had my mild traumatic brain injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe health issues that could interfere with the study.

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I have measurable issues with my nervous system.

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I have undergone TMS therapy before.

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I've had lasting symptoms from a mild brain injury within the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline across all subsequent time points until completion of the study, an average of 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline across all subsequent time points until completion of the study, an average of 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline across all subsequent time points until completion of the study, an average of 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Central target engagement, modulation, and durability

Fear avoidance modulation and durability

Peripheral target engagement, modulation, and durability

+1 more

Secondary study objectives

Daily heart rate variability

Nightly Sleep Score from Oura Ring

Weekly avoidance behavior

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Active continuous theta-burst stimulation (cTBS) plus exposureExperimental Treatment2 Interventions

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.

Group II: Active Comparator continuous theta-burst stimulation (cTBS) plus exposureActive Control2 Interventions

Group III: Inactive/Sham continuous theta-burst stimulation (cTBS) plus exposurePlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imaginal exposure

2008

N/A

~190

Active cTBS

2023

N/A

~10