Remotely Supervised tDCS for Persistent Post-traumatic Headache

NCT ID: NCT04012853

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2022-03-31

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.

Conditions

Persistent Post Traumatic Headache; Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

treatment arm

tDCS treatment group

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: 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).

control arm

Sham tDCS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transcranial direct current stimulation

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).

Intervention Type: DEVICE

Other Intervention Names

tDCS

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao M. Androulakis, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Columbia, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37213913 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

B3194-P

Identifier Type: -

Identifier Source: org_study_id