Mild Traumatic Brain Injury, Persistent Post Traumatic Headache
Conditions
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.
Interventions
DEVICEtranscranial 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).
Sponsors
New York University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6) | 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. |
| Change From Baseline in the Acute Pain Medication Days 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) | 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 | 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. |
| Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) | 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 |
| Change From Baseline in the Total Number of Headache Days Per Month | 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. |
| Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI) | 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 |
| Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ) | 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 in Scores on the Insomnia Severity Index (ISI) | 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 |
| Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5) | 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 |
Countries
United States
Participant flow
Pre-assignment details
Participants completed a 28-day baseline period in which they completed daily headache diaries to validate diagnosis of PPTH.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 13 |
| 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). | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Unable to tolerate target tDCS intensity | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Control Arm | Treatment Arm |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 9.2 | 42.2 years STANDARD_DEVIATION 8.4 | 48.4 years STANDARD_DEVIATION 9.2 |
| Beck's Anxiety Inventory (BAI) | 26.4 units on a scale STANDARD_DEVIATION 13.8 | 22.1 units on a scale STANDARD_DEVIATION 10.1 | 31.6 units on a scale STANDARD_DEVIATION 16.2 |
| Days of Acute Pain Medication Use (out of 28 days) | 10.5 days STANDARD_DEVIATION 9.4 | 9.6 days STANDARD_DEVIATION 7.9 | 11.5 days STANDARD_DEVIATION 11.3 |
| DSM-5 PTSD Checklist (PCL-5) | 44.3 units on a scale STANDARD_DEVIATION 19.2 | 42.7 units on a scale STANDARD_DEVIATION 19.2 | 46.2 units on a scale STANDARD_DEVIATION 20 |
| Education Level Bachelor's Degree or Higher | 11 Participants | 4 Participants | 7 Participants |
| Education Level High School Graduate or GED | 3 Participants | 1 Participants | 2 Participants |
| Education Level Some College or Technical School | 12 Participants | 8 Participants | 4 Participants |
| Employment Status Disabled | 4 Participants | 2 Participants | 2 Participants |
| Employment Status Employed (Full or Part-Time) | 13 Participants | 8 Participants | 5 Participants |
| Employment Status Retired | 5 Participants | 2 Participants | 3 Participants |
| Employment Status Unemployed | 4 Participants | 1 Participants | 3 Participants |
| Headache Impact Test (HIT-6) | 63.6 units on a scale STANDARD_DEVIATION 7 | 63.2 units on a scale STANDARD_DEVIATION 7.7 | 64.2 units on a scale STANDARD_DEVIATION 6.4 |
| Insomnia Sleep Index (ISI) | 17.7 units on a scale STANDARD_DEVIATION 7.4 | 17.7 units on a scale STANDARD_DEVIATION 6.7 | 17.8 units on a scale STANDARD_DEVIATION 8.5 |
| Marital Status Divorce | 5 Participants | 2 Participants | 3 Participants |
| Marital Status Married | 18 Participants | 9 Participants | 9 Participants |
| Marital Status Never Married/Domestic Partnership | 3 Participants | 2 Participants | 1 Participants |
| Medication overuse | 8 Participants | 4 Participants | 4 Participants |
| Number of Headache Days (out of 28 days) | 24.5 days STANDARD_DEVIATION 4.2 | 23.8 days STANDARD_DEVIATION 4.8 | 25.2 days STANDARD_DEVIATION 3.7 |
| Number of Moderate-to-Severe Headache Days (out of 28 days) | 16.0 days STANDARD_DEVIATION 7.4 | 14.8 days STANDARD_DEVIATION 6.4 | 16.9 days STANDARD_DEVIATION 8.3 |
| Patient Health Questionnaire (PHQ-9) | 14.3 units on a scale STANDARD_DEVIATION 5.5 | 14.3 units on a scale STANDARD_DEVIATION 4.6 | 14.3 units on a scale STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Black of African American | 13 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 26 Participants | 13 Participants | 13 Participants |
| Rivermead Post-Concussion Questionnaire (RPQ) | 42.0 units on a scale STANDARD_DEVIATION 11.2 | 42.0 units on a scale STANDARD_DEVIATION 10 | 42.0 units on a scale STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 22 Participants | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 8 / 10 | 11 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
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
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month | End of Treatment (change from baseline) | -2.5 Days per Month | Standard Deviation 3.5 |
| Treatment Arm | Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month | End of Follow-up (change from baseline) | -3.9 Days per Month | Standard Deviation 6.5 |
| Control Arm | Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month | End of Treatment (change from baseline) | 2.3 Days per Month | Standard Deviation 3.5 |
| Control Arm | Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month | End of Follow-up (change from baseline) | 1.2 Days per Month | Standard Deviation 6.5 |
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
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI) | End of Treatment (change from baseline) | -3.2 score on a scale | Standard Deviation 8.6 |
| Treatment Arm | Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI) | End of Follow-up (change from baseline) | -2.8 score on a scale | Standard Deviation 9.6 |
| Control Arm | Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI) | End of Treatment (change from baseline) | 1.9 score on a scale | Standard Deviation 10.5 |
| Control Arm | Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI) | End of Follow-up (change from baseline) | 3.5 score on a scale | Standard Deviation 10.8 |
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
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5) | End of Treatment (change from baseline) | 2.9 score on a scale | Standard Deviation 9.3 |
| Treatment Arm | Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5) | End of Follow-up (change from baseline) | -1.4 score on a scale | Standard Deviation 17.2 |
| Control Arm | Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5) | End of Treatment (change from baseline) | 1.9 score on a scale | Standard Deviation 7.4 |
| Control Arm | Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5) | End of Follow-up (change from baseline) | -1.5 score on a scale | Standard Deviation 12.4 |
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
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in Scores on the Insomnia Severity Index (ISI) | End of Follow-up (change from baseline) | -0.5 score on a scale | Standard Deviation 4.2 |
| Treatment Arm | Change From Baseline in Scores on the Insomnia Severity Index (ISI) | End of Treatment (change from baseline) | -0.5 score on a scale | Standard Deviation 5.5 |
| Control Arm | Change From Baseline in Scores on the Insomnia Severity Index (ISI) | End of Treatment (change from baseline) | 0.2 score on a scale | Standard Deviation 5.1 |
| Control Arm | Change From Baseline in Scores on the Insomnia Severity Index (ISI) | End of Follow-up (change from baseline) | 0.9 score on a scale | Standard Deviation 8.4 |
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
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) | End of Treatment (change from baseline) | -0.6 score on a scale | Standard Deviation 4.1 |
| Treatment Arm | Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) | End of Follow-up (change from baseline) | 0.1 score on a scale | Standard Deviation 4.2 |
| Control Arm | Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) | End of Treatment (change from baseline) | 0.1 score on a scale | Standard Deviation 4.4 |
| Control Arm | Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) | End of Follow-up (change from baseline) | -1.0 score on a scale | Standard Deviation 5.6 |
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
Time frame: Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ) | End of Treatment (change from baseline) | -10.2 score on a scale | Standard Deviation 19.1 |
| Treatment Arm | Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ) | End of Follow-up (change from baseline) | -4.8 score on a scale | Standard Deviation 10.6 |
| Control Arm | Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ) | End of Treatment (change from baseline) | -4.2 score on a scale | Standard Deviation 11.7 |
| Control Arm | Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ) | End of Follow-up (change from baseline) | -4.0 score on a scale | Standard Deviation 14.8 |
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
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)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in the Acute Pain Medication Days Per Month | End of Treatment (change from baseline) | -2.7 Days of Medication Use per Month | Standard Deviation 4.2 |
| Treatment Arm | Change From Baseline in the Acute Pain Medication Days Per Month | End of Follow-up (change from baseline) | 3.0 Days of Medication Use per Month | Standard Deviation 6.4 |
| Control Arm | Change From Baseline in the Acute Pain Medication Days Per Month | End of Treatment (change from baseline) | -0.4 Days of Medication Use per Month | Standard Deviation 3.7 |
| Control Arm | Change From Baseline in the Acute Pain Medication Days Per Month | End of Follow-up (change from baseline) | -2.3 Days of Medication Use per Month | Standard Deviation 10.2 |
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.
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6) | End of Treatment (change from baseline) | -4.5 units on a scale | Standard Deviation 6.5 |
| Treatment Arm | Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6) | End of Follow-up (change from baseline) | 0.8 units on a scale | Standard Deviation 5.4 |
| Control Arm | Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6) | End of Treatment (change from baseline) | -4.0 units on a scale | Standard Deviation 7.3 |
| Control Arm | Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6) | End of Follow-up (change from baseline) | -5.4 units on a scale | Standard Deviation 18.4 |
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.
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Change From Baseline in the Total Number of Headache Days Per Month | End of Treatment (change from baseline) | -4.0 days per month | Standard Deviation 5.2 |
| Treatment Arm | Change From Baseline in the Total Number of Headache Days Per Month | End of Follow-up (change from baseline) | 2.1 days per month | Standard Deviation 7.2 |
| Control Arm | Change From Baseline in the Total Number of Headache Days Per Month | End of Treatment (change from baseline) | 1.54 days per month | Standard Deviation 3.8 |
| Control Arm | Change From Baseline in the Total Number of Headache Days Per Month | End of Follow-up (change from baseline) | -0.2 days per month | Standard Deviation 4.4 |
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.
Time frame: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Treatment | 50% or greater reduction in headache days | 1 Participants |
| Treatment Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Treatment | Less than 50% reduction in headache days | 9 Participants |
| Treatment Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Follow-up | 50% or greater reduction in headache days | 2 Participants |
| Treatment Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Follow-up | Less than 50% reduction in headache days | 8 Participants |
| Control Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Follow-up | Less than 50% reduction in headache days | 11 Participants |
| Control Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Treatment | 50% or greater reduction in headache days | 0 Participants |
| Control Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Follow-up | 50% or greater reduction in headache days | 0 Participants |
| Control Arm | Number of Participants With a 50% Reduction in Headache Frequency | End of Treatment | Less than 50% reduction in headache days | 11 Participants |