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

Primary Purpose

Persistent Post Traumatic Headache, Mild Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Post Traumatic Headache

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment arm

control arm

Arm Description

tDCS treatment group

Sham tDCS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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.
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
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
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
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 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

Full Information

First Posted
July 2, 2019
Last Updated
March 21, 2023
Sponsor
VA Office of Research and Development
Collaborators
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT04012853
Brief Title
Remotely Supervised tDCS for Persistent Post-traumatic Headache
Acronym
tDCS for PTH
Official Title
Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
New York University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Post Traumatic Headache, Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
tDCS treatment group
Arm Title
control arm
Arm Type
No Intervention
Arm Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month
Description
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
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Secondary Outcome Measure Information:
Title
Change From Baseline in the Total Number of Headache Days Per Month
Description
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.
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Title
Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6)
Description
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.
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Title
Change From Baseline in the Acute Pain Medication Days Per Month
Description
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
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)
Title
Number of Participants With a 50% Reduction in Headache Frequency
Description
Number of participants with 50% or more reduction in monthly headache days (compared to baseline) will be evaluated.
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Title
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9)
Description
assess changes in patient reported depression severity - scale range from 0 to 27, with higher scores indicating more severe depression symptoms
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Title
Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5)
Description
Assess changes in patient reported PTSD-like symptoms - scale range from 0 to 80, with a lower score suggesting a lower incidence of PTSD
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Title
Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI)
Description
Assess changes in patient reported anxiety - scale range from 0 to 63, with higher score indicating greater anxiety
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Title
Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ)
Description
Assess changes in patient reported concussion-related symptoms - scale range from 0 to 64, with higher scores indicating a worse outcome
Time Frame
Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total)
Title
Change From Baseline in Scores on the Insomnia Severity Index (ISI)
Description
Assess changes in patient reported insomnia/sleep disturbances - scale range from 0 to 28, with higher scores indicating increased severity of insomnia
Time Frame
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao M. Androulakis, MD
Organizational Affiliation
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Remotely Supervised tDCS for Persistent Post-traumatic Headache

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