Clinical trial NCT04012853: Remotely Supervised tDCS for Persistent Post-traumatic Headache
Official title: Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Post Traumatic Headache
Mild Traumatic Brain Injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: New York University
First posted: 2019-07-09
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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: 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.

Eligibility criteria: Inclusion Criteria:

1. Verified history of mTBI
2. 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).
3. Verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase.
4. 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.
5. The investigators will include medication overuse headache as defined by ICHD III diagnostic criteria.
6. 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.
7. 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:

1. Unable to complete headache diary as required by protocol.
2. 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
3. Received onabotulinumtoxinA, cognitive behavior therapy, physical therapy or any other form of non-pharmacological therapy for headaches during the 4 months before screening.
4. Has a planned military deployment within the 6 months post screening.
5. Active substance abuse within last 4 months.
6. History of seizure, stroke, multiple sclerosis or other unstable neurological condition or a significant abnormal neurological examination.
7. Unable to tolerate tDCS stimulation.
8. 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.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Change From Baseline in the Total Number of 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)
measure: Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6)
timeFrame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
measure: Change From Baseline in the Acute Pain Medication Days Per Month
timeFrame: Change from baseline (four-week daily headache diary) following four-week treatment phase and four week post-treatment follow-up (12 weeks total)
measure: Number of Participants With a 50% Reduction in Headache Frequency
timeFrame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
measure: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
measure: Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5)
timeFrame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
measure: Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI)
timeFrame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
measure: Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ)
timeFrame: Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total)
measure: Change From Baseline in Scores on the Insomnia Severity Index (ISI)
timeFrame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
state: South Carolina
Study officials:
affiliation: Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
name: Xiao M. Androulakis, MD
role: PRINCIPAL_INVESTIGATOR
References: