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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

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Central target engagement, modulation, and durability

Fear avoidance modulation and durability

Peripheral target engagement, modulation, and durability

+1 more

Secondary outcome measures

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

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,127 Total Patients Enrolled

4 Trials studying Headache

592 Patients Enrolled for Headache

United States Department of DefenseFED

863 Previous Clinical Trials

227,524 Total Patients Enrolled

7 Trials studying Headache

1,320 Patients Enrolled for Headache

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who fulfills the requirements to be accepted for this clinical trial?

"This trial is searching for 75 individuals suffering from post-concussion syndrome, aged between 18 and 65. Eligible candidates must meet both conditions to be accepted into the study."

Answered by AI

Are individuals over the age of 25 being enrolled in this experiment?

"As per the outlined criteria, this trial is open to adults aged between 18 and 65. Alternatively, 843 clinical trials are available for those younger than 18 while 3150 studies can be found for seniors over 65 years old."

Answered by AI

Has the FDA granted authorization for Active continuous theta-burst stimulation (cTBS) plus exposure?

"Due to the lack of evidence on efficacy, Active continuous theta-burst stimulation (cTBS) plus exposure was rated a 2 in terms of safety as this is only at Phase 2."

Answered by AI

Is there still capacity to enroll participants in this trial?

"According to clinicaltrials.gov records, this study has concluded recruiting for participants. Initially posted on the 1st of January 2024 and edited as recently as October 7th 2023, there are currently 4295 other trials actively seeking patients within the same field."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Kevin Charles Bickart, MD, PhD 2024. "Personalized Brain Stimulation to Treat Chronic Concussive Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073886.

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