No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for people aged 18-65 who have ongoing symptoms after a concussion or mild brain injury. Participants will receive brain stimulation treatment at UCLA over several visits to see if it helps improve their symptoms.
Are You a Good Fit for This Trial?
Rules you outSevere mental problemsSevere physical problemsSevere medical problems
You may be able to join if
I have had a mild traumatic brain injury in the last 12 months.
I am aged 18-65.
I have a high burden of post-concussive symptoms.
You may not be able to join if
I have objective neurologic deficits.
I have ongoing post-concussive symptoms from a previous injury within the last 2 years.
I have a history of TMS therapy.
I have contraindications for TMS or MRI.
I have severe health problems that could interfere with the trial.
I actively abuse alcohol or illicit drugs.
I cannot speak and read English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 dif…
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.
Trial Locations
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Eligibility Criteria
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…
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
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