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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
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.
MJHS Institute for Innovation in Palliative Care
New York, New York, United States
New York Headache Center
New York, New York, United States
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.
Time frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);
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
Time frame: Day 60 of the intervention
Migraine Attack Frequency
Median change in number of attacks per 30-day period, determined from the patients' diaries
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 60 of the intervention
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