Recruiting

Theta Burst Stimulation

Sponsor:

Minneapolis Veterans Affairs Medical Center

Code:

NCT04906603

Conditions

Post-Traumatic Headache

Transcranial Magnetic Stimulation

Brain Injuries, Traumatic

Quality of Life

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Theta Burst Stimulation

Study Details

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 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.

Conditions

Post-Traumatic Headache

Transcranial Magnetic Stimulation

Brain Injuries, Traumatic

Quality of Life

Study ID

NCT04906603

Start date

Nov 1, 2019

Status verified date

May, 2021

Completion date

Sep, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TBS Headache

Interventions

Theta Burst Stimulation

TBS will be administered three times per day and three days per week for four weeks (totaling 12 TBS intervention visits and 36 TBS intervention sessions). Each TBS intervention session will last approximately 10 minutes (stimulation parameters = 50 Hz, 3 pulses, 10 bursts, 10 second cycle time, 60 cycles, 1800 total pulses).

Primary outcome measure

  • Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment [ Time Frame: Participants will take the daily headache assessment every day for 2 weeks pre-intervention, every day for 4 weeks during intervention, and every day for 4 weeks post-intervention to track their change in headache frequency, intensity, and impairment. ]
  • World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
  • Migraine Disability Assessment (MIDAS) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
  • Patient-Reported Outcomes Measurement Information System - Pain Interference - Short Form 6b (PROMIS-SF6b) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]

Central Contacts and Locations

Locations

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

More Information

Sponsor

Minneapolis Veterans Affairs Medical Center

Last update posted

May 28, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Veterans Affairs Medical Center on 2021-05-28.