Theta Burst Stimulation for Headaches After Traumatic Brain Injury

Status unconfirmed · Not applicable

Conditions studied: Post-Traumatic Headache, Transcranial Magnetic Stimulation, Brain Injuries, Traumatic, Quality of Life

In brief

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 that uses magnets to create electricity and stimulate nerve cells in the brain. After repeated TBS sessions, the increased stimulation of nerve cells can alter the way the brain communicates with itself (by creating new neural pathways) which, in turn, can reduce pain symptoms. Participants in this study will complete a baseline assessment followed by four weeks of daily home headache assessment. Participants will then receive four weeks of TBS administered three times per day and three days per week. After TBS is completed, participants will complete an additional four weeks of daily home headache assessment and return for a one-month follow-up assessment. Participation is expected to last three months.

Key facts

Study ID

NCT04906603

Run by

Minneapolis Veterans Affairs Medical Center

People needed

20

Starts

2019-11-01

Expected to finish

2023-09-01

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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