Remotely Supervised tDCS for Persistent Post-traumatic Headache

Study Overview
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Brief Summary
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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.

Detailed Description
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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 post traumatic headache (PTH) associated with mTBI, and the impact of this treatment on persistent PTH associated functional recovery. Total of 20 participants (10 treatment group, 10 sham control) will be included in this study. The investigators will also evaluate recruitment strategies and participants clinical characteristics.

Official Title
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Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache: A Pilot Study

Conditions
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Persistent Post Traumatic Headache, Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>tDCS treatment group | Device: transcranial direct current stimulation<br>* Treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20minute treatment session, both treatment and sham groups will complete mindfulness meditation via VA health system approved program (Mindfulness Coach).<br>* Other names: tDCS;|
| No Intervention: control arm<br>Sham tDCS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month | To evaluate the improvement in numbers of moderate to severe headache days per month from baseline period to end of treatment phase, and to the end of follow-up phase | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total Number of Headache Days Per Month | To evaluate improvement in total number of headache days per month, acute pain mediation used based on number of doses of medication taken from baseline period to end of treatment phase, and to end of follow-up phase in the same cohort. | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 
| Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6) | To evaluate the impact of headaches on the quality of life measures (pain and disability) based on change in Headache impact test-6 (HIT-6) from baseline period to end of treatment phase, and to end of follow-up phase in persistent PTH. The six-item Headache Impact Test (HIT-6) provides a global measure of adverse headache impact and was developed to use in screening and monitoring patients with headaches in both clinical practice and clinical research. A total HIT-6 score ranges from 36 to 78: Little or no impact = HIT-6 score 49 or less; Some impact = HIT-6 score 50-55; Substantial impact = HIT-6 score 56-59; Severe impact = HIT-6 score 60. | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 
| Change From Baseline in the Acute Pain Medication Days Per Month | change in days of acute pain medication use based on number of days taken during the baseline period to end of the treatment and follow up phase | Change from baseline (four-week daily headache diary) following four-week treatment phase and four week post-treatment follow-up (12 weeks total) | 
| Number of Participants With a 50% Reduction in Headache Frequency | Number of participants with 50% or more reduction in monthly headache days (compared to baseline) will be evaluated. | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 
| Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) | assess changes in patient reported depression severity - scale range from 0 to 27, with higher scores indicating more severe depression symptoms | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 
| Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5) | Assess changes in patient reported PTSD-like symptoms - scale range from 0 to 80, with a lower score suggesting a lower incidence of PTSD | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 
| Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI) | Assess changes in patient reported anxiety - scale range from 0 to 63, with higher score indicating greater anxiety | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) | 
| Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ) | Assess changes in patient reported concussion-related symptoms - scale range from 0 to 64, with higher scores indicating a worse outcome | Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total) | 
| Change From Baseline in Scores on the Insomnia Severity Index (ISI) | Assess changes in patient reported insomnia/sleep disturbances - scale range from 0 to 28, with higher scores indicating increased severity of insomnia | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |