Status:
UNKNOWN
Theta Burst Stimulation for Headaches After Traumatic Brain Injury
Lead Sponsor:
Minneapolis Veterans Affairs Medical Center
Collaborating Sponsors:
Minnesota Office of Higher Education
The Defense and Veterans Brain Injury Center
Conditions:
Post-Traumatic Headache
Transcranial Magnetic Stimulation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique th...
Detailed Description
The primary objective of this study is to investigate the safety and efficacy of theta burst stimulation (TBS) for the management of post-traumatic headaches to improve outcomes and quality of life fo...
Eligibility Criteria
Inclusion
- Veterans receiving services through the MVAHCS
- History of mild TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
- Loss of consciousness between 0-30 minutes
- Post-traumatic amnesia between 0-24 hours
- Alteration of consciousness/mental state up to 24 hours
- Glasgow Coma Score between 13-15 (best available score within first 24 hours)
- Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present:
- Headaches developing within seven days following trauma or injury to the head and/or neck
- Headaches persisting beyond three months
- Chronic daily headaches defined by clinical standards with the following criterion present:
- o 15 or more headache days per month
- Men and women 18-75 years of age
- Possess a smartphone and agree to download and use the EMA application on their personal device
- Capable and willing to provide voluntary informed consent
Exclusion
- History of moderate or severe TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
- Loss of consciousness greater than 30 minutes
- Post-traumatic amnesia greater than 24 hours
- Worst Glasgow Coma Scale less than 13 within the first 24 hours unless invalidated upon review (e.g., attributable to intoxication, sedation, systemic shock)
- Abnormal structural imaging
- Current (within six months of enrollment) psychosis and mania
- Current (within one month of enrollment) substance dependence with the exclusion of opioids
- Personal history of epilepsy or seizure disorder
- o Does not include seizures therapeutically-induced by ECT or identified as a single seizure event (based on the principal investigator's judgement)
- Metal particles in the eye or head (exclusive of the mouth) (e.g., shrapnel, fragments from welding or metalwork, etc.)
- Implanted medical device above the clavicle (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes, etc.)
- Significant neurological disorder or insult that would impact risk (based on the principal investigator's judgement and research literature)
- Current use of medications with significant potential for lowering seizure threshold
- Current benzodiazepine usage at a dose higher than 3mg of lorazepam or equivalent
- Electroconvulsive therapy (ECT) or cortical energy exposure within one month of enrollment (including participation in any other neuromodulation treatments or studies)
- Current (within one month of enrollment) participation in another interventional study that would impact the results of this research
- Inadequate communication (e.g., language barrier)
- Women who are pregnant, trying to become pregnant, or breastfeeding
- Women of childbearing age/potential who are not using a medically-accepted form of contraception when sexually active
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04906603
Start Date
November 1 2019
End Date
September 1 2023
Last Update
May 28 2021
Active Locations (1)
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1
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417