A Study of Home-Delivered Neurostimulation for Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): non-invasive transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine;; transcranial direct current stimulation (tDCS); tDCS-Telehealth intervention