| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Persistent Post Traumatic Headache Mild Traumatic Brain Injury | Device: transcranial direct current stimulation | Not Applicable |
| 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 |
| 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
|
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No Intervention: control arm
Sham tDCS
|
| Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| 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 |
| 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 | |
| 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 |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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 |
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| Condition ICMJE |
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| 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
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 60 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||||
| Collaborators ICMJE | New York University | ||||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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