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Brain Stimulation

Theta Burst Stimulation for Post-Traumatic Headache

N/A
Waitlist Available
Research Sponsored by Minneapolis Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Loss of consciousness between 0-30 minutes
Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Awards & highlights

Study Summary

This trial is testing whether a brain stimulation technique called theta burst stimulation can help to reduce chronic headaches caused by a traumatic brain injury. The treatment involves having magnets placed on the head to create electrical impulses and stimulate the brain. The hope is that this will help to retrain the brain and reduce pain symptoms. The trial will last for 3 months.

Eligible Conditions
  • Post-Traumatic Headache
  • Transcranial Magnetic Stimulation
  • Traumatic Brain Injury
  • Quality of Life

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have experienced a period of unconsciousness that lasted for up to 30 minutes.
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You have headaches after a head injury that meet specific criteria outlined by the International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines.
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You experienced memory loss for a period of time right after a traumatic event, lasting between 0 and 24 hours.
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You have experienced changes in your thinking or awareness within the past 24 hours.
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Your Glasgow Coma Score, which measures your level of consciousness, needs to be between 13 and 15 within the first 24 hours after the incident.
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You have had headaches within one week after a head or neck injury.
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You have had constant headaches for more than three months.
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You have frequent headaches every day that meet certain medical criteria.
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You experience headaches on 15 or more days every month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment
Migraine Disability Assessment (MIDAS)
Patient-Reported Outcomes Measurement Information System - Pain Interference - Short Form 6b (PROMIS-SF6b)
+1 more
Secondary outcome measures
Barratt Impulsiveness Scale - Version 11 (BIS-11)
Beck Anxiety Inventory (BAI)
Caffeine and Nicotine Use Questionnaire
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TBS HeadacheExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Theta Burst Stimulation
2014
N/A
~40

Find a Location

Who is running the clinical trial?

Minneapolis Veterans Affairs Medical CenterLead Sponsor
71 Previous Clinical Trials
14,882 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
525 Patients Enrolled for Post-Traumatic Headache
Minnesota Office of Higher EducationOTHER_GOV
4 Previous Clinical Trials
174 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
39 Patients Enrolled for Post-Traumatic Headache
The Defense and Veterans Brain Injury CenterFED
19 Previous Clinical Trials
2,701 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
35 Patients Enrolled for Post-Traumatic Headache

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining vacancies for individuals to join this experiment?

"According to its listing on clinicaltrials.gov, this medical study is presently enrolling patients and has been since November 1st 2019. The trial was last updated on May 26th 2021."

Answered by AI

Does this research encompass participants aged 45 or above?

"As per the entry requirements for this medical trial, individuals must be at least 18 years of age and not exceed 75."

Answered by AI

What objectives is the medical trial attempting to accomplish?

"This trial will be measured across four stages: Baseline, pre-intervention (2 weeks post baseline), post-intervention (4 weeks after pre-intervention) and follow up (1 month from post intervention). The primary outcome to be assessed is Ecological Momentary Assessment of Headache Frequency, Intensity and Impairment. Secondary objectives include assessing changes in moods via Beck Anxiety Inventory (BAI) rated on a 4 point scale, PTSD Checklist for DSM - V(PCL 5) scored on a 5 point rating scale, as well as Risk Task which is conducted through a computerized behavioural intervention."

Answered by AI

What is the participant capacity for this clinical trial?

"Affirmative. The clinical trial's data hosted on the website clinicaltrials.gov suggests that this study is actively seeking participants. It was first advertised on November 1st 2019 and recently updated for the last time on May 26th 2021, recruiting 20 individuals from one medical centre in total."

Answered by AI

Is my profile compatible with the parameters of this research project?

"This clinical trial seeks 20 volunteers, aged 18-75 with cervicogenic headache. Additional criteria to be eligible for the study include a Glasgow Coma Score of 13-15 in the first 24 hours post injury or trauma, an alteration of consciousness/mental state that does not exceed 24 hours following head or neck impact, headaches persisting beyond three months and 15 or more days per month with such pain symptoms; participants must also have access to a smartphone and consent to download and use the EMA application on their device."

Answered by AI
~4 spots leftby Mar 2025