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| Name | Class |
|---|---|
| New York University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | tDCS treatment group |
|
| control arm | No Intervention | Sham tDCS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao M. Androulakis, MD | Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC | Columbia | South Carolina | 29209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37213913 | Derived | 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. |
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Participants completed a 28-day baseline period in which they completed daily headache diaries to validate diagnosis of PPTH.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Active tDCS group The active tDCS 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 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). |
| FG001 | Control Arm | Sham tDCS group Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were randomly assigned to either the Treatment arm or the Control arm after successful completion of a 28-day baseline period. During this periods participants completed daily headache diaries to establish baseline headache characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Active tDCS group The active tDCS 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 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | Days per Month | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Active tDCS group The active tDCS 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 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment | Tingling sensation beneath tDCS electrode |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. X. Michelle Androulakis Chief of Neurology | WJB Dorn VA Medical Center | 803-776-4000 | 4077 | xiao.androulakis@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2019 | Jan 27, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2021 | Feb 14, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2021 | Apr 21, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
|
| 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. | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) |
| Unable to tolerate target tDCS intensity |
|
| Control Arm |
Sham tDCS group Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Number of Headache Days (out of 28 days) | Mean | Standard Deviation | days |
|
| Number of Moderate-to-Severe Headache Days (out of 28 days) | Mean | Standard Deviation | days |
|
| Days of Acute Pain Medication Use (out of 28 days) | Mean | Standard Deviation | days |
|
| Medication overuse | Count of Participants | Participants |
|
| Patient Health Questionnaire (PHQ-9) | scale range from 0 to 27, with higher scores indicating more severe depression symptoms | Mean | Standard Deviation | units on a scale |
|
| Headache Impact Test (HIT-6) | scale range from 36 to 78, with higher scores indicating more substantial functional impairment | Mean | Standard Deviation | units on a scale |
|
| Beck's Anxiety Inventory (BAI) | scale range from 0 to 63, with higher score indicating greater anxiety | Mean | Standard Deviation | units on a scale |
|
| DSM-5 PTSD Checklist (PCL-5) | scale range from 0 to 80, with a lower score suggesting a lower incidence of PTSD | Mean | Standard Deviation | units on a scale |
|
| Insomnia Sleep Index (ISI) | scale range from 0 to 28, with higher scores indicating increased severity of insomnia | Mean | Standard Deviation | units on a scale |
|
| Rivermead Post-Concussion Questionnaire (RPQ) | scale range from 0 to 64, with higher scores indicating a worse outcome | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Arm | Sham tDCS group Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). * 1 participant was excluded due to being an outlier on multiple measures |
|
|
| Secondary | 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. | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | days per month | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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. | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | units on a scale | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | Days of Medication Use per Month | Change from baseline (four-week daily headache diary) following four-week treatment phase and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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. | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Count of Participants | Participants | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | score on a scale | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | score on a scale | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | score on a scale | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| Secondary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | score on a scale | Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total) |
|
|
|
| Secondary | 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 | Analysis was conducted on participants completing post-treatment, and follow-up evaluations | Posted | Mean | Standard Deviation | score on a scale | Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | Control Arm | Sham tDCS group Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach). | 0 | 12 | 0 | 12 | 11 | 12 |
|
| Prickling Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment | Prickling sensation beneath tDCS electrode |
|
| Warming Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment | Warming sensation beneath the tDCS electrode |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | Itching beneath the tDCS electrode |
|
| Redness/Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment | Redness or dry skin beneath the tDCS electrode |
|
| Numbing Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment | Numbness beneath the tDCS electrode |
|
| Pulsing/Throbbing | General disorders | Systematic Assessment | Pulsing of throbbing sensation beneath the tDCS electrode |
|
| Dizziness/Lightheaded | General disorders | Systematic Assessment | Feeling dizzy or lightheaded during/after treatment session |
|
| Vertigo | General disorders | Systematic Assessment | Feeling of vertigo during/after treatment session |
|
| Fatigue | General disorders | Systematic Assessment | Feeling of increased fatigue during/after treatment session |
|
| Other | General disorders | Systematic Assessment | Feeling one of the following during/after treatment: pain, sharp sensations, back pain, pressure, and/or eye twitches (each reported by <= 1 participant) |
|
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| End of Follow-up |
|