Status:
COMPLETED
Remotely Supervised tDCS for Persistent Post-traumatic Headache
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
New York University
Conditions:
Persistent Post Traumatic Headache
Mild Traumatic Brain Injury
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
This pilot study is designed to provide preliminary data for a large scale, randomized clinical trial to evaluate the efficacy of remotely administrated at home transcranial Direct Current Stimulation...
Detailed Description
The aim of this study is to evaluate the feasibility and efficacy of transcranial Direct Current Stimulation (tDCS) administered at home with real-time monitoring via VA Tele-health for persistent pos...
Eligibility Criteria
Inclusion
- Verified history of mTBI
- Persistent PTH as defined by International Classification of Headache Disorders (ICHD) III diagnostic criteria("Headache Classification Committee of the International Headache Society (IHS) The ICHD, 3rd Edition 2018).
- Verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase.
- Not currently taking a migraine or headache preventive medication OR has been taking a stable dose of a preventive for at least 60 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
- The investigators will include medication overuse headache as defined by ICHD III diagnostic criteria.
- Participants is either not of childbearing potential, or if they are of childbearing potential, they agree either to remain abstinent or use (or have their partner use) an acceptable method of birth control for the duration of the study.
- Male or female, age between 20-60 who demonstrates compliance with the electronic Daily Headache Diary during the 28-day baseline phase as defined by entry of headache data on a minimum of 22 to 28 days (80% diary compliance).
Exclusion
- Unable to complete headache diary as required by protocol.
- Any psychiatric condition with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in the ability to complete study activities
- Received onabotulinumtoxinA, cognitive behavior therapy, physical therapy or any other form of non-pharmacological therapy for headaches during the 4 months before screening.
- Has a planned military deployment within the 6 months post screening.
- Active substance abuse within last 4 months.
- History of seizure, stroke, multiple sclerosis or other unstable neurological condition or a significant abnormal neurological examination.
- Unable to tolerate tDCS stimulation.
- Have any other conditions that in the judgment of the Investigator would make the participants unsuitable for inclusion or interfere with participating or completing the study.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04012853
Start Date
November 4 2019
End Date
March 31 2022
Last Update
April 14 2023
Active Locations (1)
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1
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, United States, 29209