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出境医 / 临床实验 / Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache (tDCS for PTH)

Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache (tDCS for PTH)

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.

Condition or disease Intervention/treatment Phase
Persistent Post Traumatic Headache Mild Traumatic Brain Injury Device: transcranial direct current stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remotely Supervised tDCS for Persistent Post-traumatic Headache: A Pilot Study
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021
Arms and Interventions
Arm Intervention/treatment
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 Name: tDCS

No Intervention: control arm
Sham tDCS
Outcome Measures
Primary Outcome Measures :
  1. number of moderate to severe headache days per month [ Time Frame: through study completion, an average of 2 years ]
    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 :
  1. total number of headache days per month [ Time Frame: through study completion, an average of 2 years ]
    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.

  2. quality of life based on change in Headache impact test-6 (HIT-6) [ Time Frame: through study completion, an average of 2 years ]
    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.

  3. acute pain medication use [ Time Frame: through study completion, an average of 2 years ]
    change in acute pain medication use based on number of doses of medication taken from baseline period to end of the treatment and follow up phase

  4. phq-9, bai, plC-5, pcs and insominia survey [ Time Frame: through study completion, an average of 2 years ]
    part of the QoL measures to evaluate the impact of headaches.

  5. 50% reduction in headache frequency [ Time Frame: through study completion, an average of 2 years ]
    percentage of participants with 50% of more reduction in monthly headache days will be evaluated.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Xiao M Androulakis, MD (803) 776-4000 ext 4077 Xiao.Androulakis@va.gov
Contact: Kathlyn S Haddock, PhD RN (803) 776-4000 ext 6670 Kathlyn.Haddock@va.gov

Locations
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United States, South Carolina
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC Recruiting
Columbia, South Carolina, United States, 29209
Contact: Andrew E Barden    803-776-4000 ext 6632    Andrew.Barden@va.gov   
Principal Investigator: Xiao M. Androulakis, MD         
Sponsors and Collaborators
VA Office of Research and Development
New York University
Investigators
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Principal Investigator: Xiao M. Androulakis, MD Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
number of moderate to severe headache days per month [ Time Frame: through study completion, an average of 2 years ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
  • total number of headache days per month [ Time Frame: through study completion, an average of 2 years ]
    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.
  • quality of life based on change in Headache impact test-6 (HIT-6) [ Time Frame: through study completion, an average of 2 years ]
    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.
  • acute pain medication use [ Time Frame: through study completion, an average of 2 years ]
    change in acute pain medication use based on number of doses of medication taken from baseline period to end of the treatment and follow up phase
  • phq-9, bai, plC-5, pcs and insominia survey [ Time Frame: through study completion, an average of 2 years ]
    part of the QoL measures to evaluate the impact of headaches.
  • 50% reduction in headache frequency [ Time Frame: through study completion, an average of 2 years ]
    percentage of participants with 50% of more reduction in monthly headache days will be evaluated.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • total number of headache days per month [ Time Frame: through study completion, an average of 2 years ]
    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.
  • quality of life [ Time Frame: through study completion, an average of 2 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache
Official Title  ICMJE Remotely Supervised tDCS for Persistent Post-traumatic Headache: A Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Persistent Post Traumatic Headache
  • Mild Traumatic Brain Injury
Intervention  ICMJE 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 Name: tDCS
Study Arms  ICMJE
  • Experimental: treatment arm
    tDCS treatment group
    Intervention: Device: transcranial direct current stimulation
  • No Intervention: control arm
    Sham tDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiao M Androulakis, MD (803) 776-4000 ext 4077 Xiao.Androulakis@va.gov
Contact: Kathlyn S Haddock, PhD RN (803) 776-4000 ext 6670 Kathlyn.Haddock@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012853
Other Study ID Numbers  ICMJE B3194-P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE New York University
Investigators  ICMJE
Principal Investigator: Xiao M. Androulakis, MD Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
PRS Account VA Office of Research and Development
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP