Remotely Supervised tDCS for Persistent Post-traumatic Headache

NCT04012853 | Completed Results DMC FDA Device

• 1 other identifier: B3194-P
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Post Traumatic Headache; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline in the Total Number of Headache Days Per Month

  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)

  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 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

  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)

  Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)

Study Arms (2)

treatment arm

EXPERIMENTAL

tDCS treatment group

Device: transcranial direct current stimulation

control arm

NO INTERVENTION

Sham tDCS

Interventions

transcranial direct current stimulation DEVICE

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).

Also known as: tDCS

treatment arm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• New York University: collaborator

Study Sites (1)

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209, United States

Location

Related Publications (1)

• Charvet L, Harrison AT, Mangold K, Moore RD, Guo S, Zhang J, Datta A, Androulakis XM. Remotely supervised at-home tDCS for veterans with persistent post-traumatic headache: a double-blind, sham-controlled randomized pilot clinical trial. Front Neurol. 2023 May 5;14:1184056. doi: 10.3389/fneur.2023.1184056. eCollection 2023.

  PMID: 37213913 DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. X. Michelle Androulakis Chief of Neurology
• Organization: WJB Dorn VA Medical Center

xiao.androulakis@va.gov

803-776-4000

Study Officials

• Xiao M. Androulakis, MD

  Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: November 4, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)