Remotely Supervised tDCS for Persistent Post-traumatic Headache
United States26 participantsStarted 2019-11-04
Plain-language 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 (tDCS) with real-time monitoring via VA Tele-health for persistent post traumatic headache associated with mild traumatic brain injury (mTBI). Participants will receive total of 20 sessions of tDCS over four weeks. The investigators anticipate that the results generated from the study will directly translate into immediate meaningful clinical application: not only in management of chronic post traumatic headache, but also in reduction of acute pain medication use, and improving quality of life for our veterans with this debilitating neurological disorder.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a non-invasive brain stimulation technique called tDCS delivered remotely from home — could you explain how that works and whether it's something that might be appropriate to discuss for my situation with post-traumatic headaches?
2Since this trial has already been completed, have the results been published yet, and if so, did the data show any meaningful reduction in the number of moderate-to-severe headache days per month for participants?
3The trial specifically focused on people with persistent post-traumatic headache following mild traumatic brain injury — how would you determine whether my headache history and injury profile are similar enough to the study population that its findings might be relevant to my care?
4Because this was listed as Phase NA, which often means it's a feasibility or pilot study rather than a large definitive trial, how much confidence can we place in whatever results were found, and what further research would need to happen before tDCS became a standard option?
5Are there currently standard treatments for persistent post-traumatic headache that I should consider trying first, and how would you weigh those against exploring newer approaches like the remote tDCS method studied in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
. 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 criteria
. 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.