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Behavioural Intervention
TMS for MTBI-related Headaches
N/A
Waitlist Available
Led By Albert Yick Leung, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the measure will be assessed at the baseline visit, 1-week, 1-month, 2-month and 3-month post-treatment follow up visits.
Awards & highlights
Study Summary
This trial is testing whether a treatment called repetitive transcranial magnetic stimulation (rTMS) can help reduce headaches in military personnel with mild traumatic brain injury (MTBI).
Who is the study for?
This trial is for military personnel with mild traumatic brain injury (MTBI) who suffer from persistent headaches. Participants must have experienced symptoms like feeling dazed or confused, and a loss of consciousness for less than 30 minutes after the injury. They should not have had chronic headaches before the MTBI or any experience with TMS treatment. Those with pacemakers, metal in their body, history of seizures, major psychiatric diseases, or active substance dependence cannot join.Check my eligibility
What is being tested?
The study tests if repetitive transcranial magnetic stimulation (rTMS) can manage headaches caused by MTBI over a period of 2-3 months. It compares the effects of actual rTMS treatment to sham (fake) rTMS to see which is more effective at reducing headache intensity and frequency.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of rTMS may include discomfort at the site on the head where the magnet is placed during treatment, lightheadedness, temporary hearing issues due to noise during session, and in rare cases could induce seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the measure will be assessed at the baseline visit, 1-week, 1-month, 2-month and 3-month post-treatment follow up visits.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the measure will be assessed at the baseline visit, 1-week, 1-month, 2-month and 3-month post-treatment follow up visits.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline to Post-Treatment Depression scores
Change from Baseline to Post-Treatment Executive Functioning
Change from Baseline to Post-Treatment Global Pain scores.
+5 moreSecondary outcome measures
Explore the treatment effect on the pain related network of the brain
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial Magnetic StimulationExperimental Treatment1 Intervention
Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.
Group II: Sham Transcranial Magnetic StimulationPlacebo Group1 Intervention
Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,424 Total Patients Enrolled
Albert Yick Leung, MDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
2 Previous Clinical Trials
137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- feeling confused or disorientedYou have had a pacemaker implanted in the past.You have another ongoing chronic nerve pain condition.You have been diagnosed with migraines, tension headaches, or cluster headaches before the head injury.You did not have daily headaches before the head injury occurred.You have metal in your body that would prevent you from having a brain MRI.You have had a seizure in the past.You must have been diagnosed with a mild traumatic brain injury according to specific guidelines.You have a history of serious mental illness or life-threatening diseases.You had frequent headaches that lasted more than an hour before the head injury occurred.You have not received TMS treatment before.You have recently had a significant increase in depressive or anxiety symptoms, are currently dependent on drugs or alcohol, have had thoughts of suicide or attempted suicide in the last month, or are currently experiencing psychotic symptoms.You have frequent and severe headaches, with a score higher than 30 on a special scale and higher than 3 out of 10 on a headache diary.You are confused or have trouble knowing where you are or what is happening around you.After 30 minutes, you have a Glasgow Coma Scale score between 13 and 15.It seems like there might be a mistake in the information provided. If you have a specific criterion in mind that you'd like to have summarized, please provide the details, and I'd be happy to help!You have lost consciousness for about 30 minutes or less.You did not have memory loss for more than 24 hours after a head injury.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Transcranial Magnetic Stimulation
- Group 2: Transcranial Magnetic Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical study accommodate seniors aged seventy or older?
"Patients aged between 18 and 65 are eligible for this clinical trial."
Answered by AI
How many participants are currently enlisted in this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that the recruitment for this clinical trial is ongoing, having been first posted on January 1st 2018 and recently updated on March 23rd 2022. The project needs to enrol 128 individuals amongst one location."
Answered by AI
Are registration opportunities still available for this investigation?
"Clinicaltrials.gov has confirmed that this clinical trial, whose first iteration was published on the 1st of January 2018 and amended most recently on March 23rd 2022 is actively recruiting patients."
Answered by AI
Am I a viable candidate to join this clinical investigation?
"Candidates wishing to partake in this clinical trial should possess a traumatic brain injury (TBI) and be between the ages of 18-65. A total of 128 participants are expected to take part in the study."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
How old are they?
18 - 65
What site did they apply to?
VA San Diego Healthcare System, San Diego, CA
What portion of applicants met pre-screening criteria?
Met criteria
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