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| Name | Class |
|---|---|
| New York Headache Center | OTHER |
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There is a need for better preventive and abortive therapies for migraine. Previous research has indicated that non-invasive neurostimulation may have prophylactic effects on migraine and improve symptoms and functional outcomes in migraineurs. One such method is a non-invasive transcranial direct current stimulation (tDCS). This double-blind randomized sham-controlled two-parallel-arm study aims to evaluate efficacy and safety of tDCS self-delivered in daily 20-minute applications for 2 months (60 days) by adult migraine patients at home for migraine prevention and migraine symptom management, as compared to sham tDCS application; and to evaluate patients' satisfaction with the procedure.
This study will employ a double-blind randomized sham-controlled two-parallel-arm design and involve 60 adults with migraine. For each participant, the study will involve 3 study visits and last about 90 days (30 days of the baseline followed by 60 days of the tDCS/sham study intervention). A post-study safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.
At Visit 1, patients will provide written informed consent and undergo screening for the eligibility. This will be followed by 30 days of baseline at home during which patients will keep daily records (Daily Diaries) of migraine occurrence and provide answers to a set of symptom-related questionnaires. Patients with 4 or more migraine days per month who fully meet the study eligibility criteria at the end of the baseline period will be randomized in double-blind manner into two groups: Group 1 will be randomized to receive active tDCS in daily 20-minute applications for 60 days; Group 2 will be randomized to receive sham tDCS in daily 20-minute applications for 60 days, self-applied at home. Following randomization, patients will continue keeping the Daily Diaries and Visit #2 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be deployed to the patient and instructions on tDCS use will be provided. The first tDCS/sham self-application by the patient will be done at Visit 2. Daily tDCS/sham self-application by the patient at home and records in the form of Daily Diaries will continue for the rest of the 60-day period. Study staff will be in regular remote contact with the patient via phone and/or HIPAA-compliant videoconferencing. Upon conclusion of the intervention, Visit 3 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be collected from the patient. Safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.
Outcome assessment will be carried out at the end of the baseline, and at Day 30 (the secondary time-point) and Day 60 (the primary time-point) of the tDCS/sham intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Twenty minutes of direct current at intensity of 1.5 milliamperes (mA). |
|
| Sham tDCS | Sham Comparator | Thirty seconds of direct current at 1.5 mA, followed by 0 mA for the remaining time of the 20-minute stimulation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive transcranial direct current stimulation (tDCS) | Device | Active tDCS: transcranial direct current stimulation at intensity 1.5mA for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. Sham tDCS: transcranial direct current stimulation at intensity 1.5mA for 30seconds followed by 0 mA current for remaining time of the 20-minute intervention per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Days Per Month | A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day. | Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders | determined as a percentage of patients having at least 50% reduction of monthly migraine days between the one-month baseline and post-intervention, in each of the two study groups | Day 60 of the intervention |
| Migraine Attack Frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Knotkova, PhD | MJHS Institute for Innovation in Palliative Care (MJHSPalliative) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MJHS Institute for Innovation in Palliative Care | New York | New York | 10006 | United States | ||
| New York Headache Center |
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Thirty six patients have been identified. Six declined to participate, 14 did not meet the Inclusion/Exclusion criteria. Twenty two proceeded with the study, were randomized and received the study intervention. The first of the twenty-two patients entered the study on 4/22/19; the last patient out completed the study intervention on 4/10/2020, with the last study visit on 4/13/2020 and the last phone follow-up on 5/12/2020.
Participants were recruited at the New York Headache Center, New York City, NY, USA, between 3/12/2019 and 3/5/2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA). non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
| FG001 | Sham tDCS | Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time. non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA). non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Migraine Days Per Month | A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day. | Participants who met the Inclusion/Exclusion criteria for the study. | Posted | Median | Inter-Quartile Range | migraine days per month | Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); |
|
Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).
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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 | Active tDCS | The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA). non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helena Knotkova, PhD, PhilD | MJHS Institute for Innovation in Palliative Care, New York, NY | 646-784-2262 | HKnotkov@mjhs.org |
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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 | Feb 26, 2019 | Sep 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2020 | Nov 4, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
Median change in number of attacks per 30-day period, determined from the patients' diaries |
| Baseline, Day 30 of the intervention, Day 60 of the intervention |
| Acute Medication Use | Acute antimigraine drug use per month determined from the patient's diaries. Median change in number of days on which an acute medication was used. | Baseline, Day 30 of the intervention, Day 60 of the intervention |
| Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period | Determined from the 11-point [0-10] Pain Numerical Rating Scale (Pain NRS) on migraine days in the patients' diaries. Higher ratings on the Pain NRS reflect higher intensity of pain. | Baseline, Day 30 of the intervention, Day 60 of the intervention; |
| Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ) | Determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated on a scale 1-6, with the total score ranging between 14 and 84. Higher scores reflect poorer quality of life. | Baseline, Day 30 of the intervention, Day 60 of the intervention; |
| Change in Depressive Symptoms | Determined from the Hamilton Depression Scale (HamD) that consists of 21 items with numerically rated responses ranging 0-2 or 0-4. Higher Ham-D score reflects more severe depression. | Baseline, Day 30 of the intervention, Day 60 of the intervention; |
| Tolerability of the Study Intervention: Number of Side Effects and Adverse Events | Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention | from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application |
| Patient's Satisfaction: 8-item tDCS User Survey | Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure. | Day 60 of the intervention |
| New York |
| New York |
| 10021 |
| United States |
| BG001 | Sham tDCS | Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time. non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Migraine days per month | Number of migraine days per month, as reported by participants. | Median | Inter-Quartile Range | migraine days per month |
|
| OG001 | Sham tDCS | Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time. non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. |
|
|
| Secondary | Percentage of Responders | determined as a percentage of patients having at least 50% reduction of monthly migraine days between the one-month baseline and post-intervention, in each of the two study groups | Participants who met the Inclusion/Exclusion criteria of the study | Posted | Number | percentage of participants | Day 60 of the intervention |
|
|
|
| Secondary | Migraine Attack Frequency | Median change in number of attacks per 30-day period, determined from the patients' diaries | Participants who met the Inclusion/Exclusion criteria of the study. | Posted | Median | Inter-Quartile Range | migraine attacks per month | Baseline, Day 30 of the intervention, Day 60 of the intervention |
|
|
|
| Secondary | Acute Medication Use | Acute antimigraine drug use per month determined from the patient's diaries. Median change in number of days on which an acute medication was used. | Participants who met the Inclusion/Exclusion criteria of the study | Posted | Median | Inter-Quartile Range | Days/month | Baseline, Day 30 of the intervention, Day 60 of the intervention |
|
|
|
| Secondary | Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period | Determined from the 11-point [0-10] Pain Numerical Rating Scale (Pain NRS) on migraine days in the patients' diaries. Higher ratings on the Pain NRS reflect higher intensity of pain. | Participants who met the Inclusion/Exclusion criteria of the study. | Posted | Median | Inter-Quartile Range | Score on a scale | Baseline, Day 30 of the intervention, Day 60 of the intervention; |
|
|
|
| Secondary | Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ) | Determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated on a scale 1-6, with the total score ranging between 14 and 84. Higher scores reflect poorer quality of life. | Participants who met the Inclusion/Exclusion criteria of the study. | Posted | Median | Inter-Quartile Range | Score on a scale | Baseline, Day 30 of the intervention, Day 60 of the intervention; |
|
|
|
| Secondary | Change in Depressive Symptoms | Determined from the Hamilton Depression Scale (HamD) that consists of 21 items with numerically rated responses ranging 0-2 or 0-4. Higher Ham-D score reflects more severe depression. | Participants who met the Inclusion/Exclusion criteria of the study | Posted | Median | Inter-Quartile Range | Score on a scale | Baseline, Day 30 of the intervention, Day 60 of the intervention; |
|
|
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| Secondary | Tolerability of the Study Intervention: Number of Side Effects and Adverse Events | Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention | Participants who met the Inclusion/Exclusion criteria of the study. | Posted | Number | events | from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application |
|
|
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| Secondary | Patient's Satisfaction: 8-item tDCS User Survey | Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure. | Participants who met the Inclusion/Exclusion criteria of the study | Posted | Number | number of Agree/Strongly Agree ratings | Day 60 of the intervention |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Sham tDCS | Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time. non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. | 0 | 11 | 0 | 11 | 1 | 11 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |