Remotely Supervised tDCS for Persistent Post-traumatic Headache (tDCS for PTH)

March 21, 2023 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treatment arm
tDCS treatment group
Device: 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).
Other Names:
  • tDCS
No Intervention: control arm
Sham tDCS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Total Number of Headache Days Per Month
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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)
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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
Time Frame: Change from baseline (four-week daily headache diary) following four-week treatment phase and four week post-treatment follow-up (12 weeks total)
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
Time Frame: 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 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)
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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)
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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)
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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)
Time Frame: Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total)
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)
Time Frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B3194-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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