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A Study of Home-Delivered Neurostimulation for Migraine

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ClinicalTrials.gov Identifier: NCT03874351
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
New York Headache Center
Information provided by (Responsible Party):
MJHS Institute for Innovation in Palliative Care

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE March 20, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
Change in number of migraine days per month [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Percentage of responders [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
    determined as a number 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
  • Change in monthly migraine attack frequency [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
    determined from the patients' diaries
  • Change in acute medication use [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
    change in monthly acute antimigraine drug use determined from the patient's diaries
  • Change in mean headache severity per migraine day [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
    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.
  • Change in quality of life: The Migraine Specific Quality of Life Questionnaire (MSQ) [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
    determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated 0-6. Higher scores reflect poorer quality of life.
  • Change in depressive symptoms [ Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); ]
    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.
  • Tolerability of the study intervention: number of side effects and adverse events [ Time Frame: from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application ]
    determined as number of side effects and adverse events related, probably related or possibly related to the study intevention
  • Patient's satisfaction: 8-item tDCS User Survey [ Time Frame: Day 60 of the intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Home-Delivered Neurostimulation for Migraine
Official Title  ICMJE A Randomized Sham-Controlled Study of Home-Delivered Non-Invasive Neurostimulation for Migraine
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE Device: 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.
Study Arms  ICMJE
  • Experimental: Active tDCS
    The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
    Intervention: Device: non-invasive transcranial direct current stimulation (tDCS)
  • Sham Comparator: Sham tDCS
    Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
    Intervention: Device: non-invasive transcranial direct current stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 - 65 years;
  • Has episodic or chronic migraine with or without aura, diagnosed according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria, for at least the past 12 months;
  • Migraine occurring on 4 or more days per month, as documented through the 30-day baseline;
  • No change in prophylactic therapy in 3 months preceding the baseline;
  • If on antidepressant, blood pressure or epilepsy medication for reason other than migraine, the medication regimen is stable for at least 3 months preceding the baseline; Able to follow instructions in English;
  • Understand the informed consent process and provide consent to participate in the study.

Exclusion Criteria:

  • History of severe head trauma, brain surgery, implants in the head or neck; history of seizures;
  • Skin disorder or skin defects which compromise the integrity or sensitivity of the skin at or near locations where tDCS will be applied;
  • Not able to prepare and operate the tDCS device after being instructed in tDCS use;
  • Not able to respond to questionnaires and rating scales;
  • Concurrent use of another neurostimulation device (such as spinal cord stimulator cardiostimulator, deep brain stimulator, vagus nerve, transcranial magnetic, or supraorbital transcutaneous electric nerve stimulators);
  • Concurrent use of Botox or calcitonin gene-related peptide (CGRP) monoclonal antibodies treatments;
  • Unstable acute medical condition;
  • Any serious, malignant or non-malignant, acute or chronic medical condition or active psychiatric illness that, in the Investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;
  • Used any investigational drug, biologic, or device within 30 days prior to screening, or 5 half-lives, whichever is longer;
  • Taking opioid analgesics or barbiturates on more than 2 days a week;
  • Taking medications acting as antagonist on the N-methyl-D-aspartate (NMDA) receptor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Helena Knotkova, PhD 212-440-1946 HKnotkov@mjhs.org
Contact: Alexander Mauskop, MD 914-830-5344 amauskop@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874351
Other Study ID Numbers  ICMJE 19008-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MJHS Institute for Innovation in Palliative Care
Study Sponsor  ICMJE MJHS Institute for Innovation in Palliative Care
Collaborators  ICMJE New York Headache Center
Investigators  ICMJE
Principal Investigator: Helena Knotkova, PhD MJHS Institute for Innovation in Palliative Care (MJHSPalliative)
PRS Account MJHS Institute for Innovation in Palliative Care
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP