- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874351
A Study of Home-Delivered Neurostimulation for Migraine
A Randomized Sham-Controlled Study of Home-Delivered Non-Invasive Neurostimulation for Migraine
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- New York Headache Center
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New York, New York, United States, 10006
- MJHS Institute for Innovation in Palliative Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active tDCS
Twenty minutes of direct current at intensity of 1.5 milliamperes (mA).
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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. |
Sham Comparator: Sham tDCS
Thirty seconds of direct current at 1.5 mA, followed by 0 mA for the remaining time of the 20-minute stimulation period.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Migraine Days Per Month
Time Frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);
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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.
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Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Responders
Time Frame: Day 60 of the intervention
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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
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Day 60 of the intervention
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Migraine Attack Frequency
Time Frame: Baseline, Day 30 of the intervention, Day 60 of the intervention
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Median change in number of attacks per 30-day period, determined from the patients' diaries
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Baseline, Day 30 of the intervention, Day 60 of the intervention
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Acute Medication Use
Time Frame: Baseline, Day 30 of the intervention, Day 60 of the intervention
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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.
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Baseline, Day 30 of the intervention, Day 60 of the intervention
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Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period
Time Frame: Baseline, Day 30 of the intervention, Day 60 of the intervention;
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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.
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Baseline, Day 30 of the intervention, Day 60 of the intervention;
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Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)
Time Frame: Baseline, Day 30 of the intervention, Day 60 of the intervention;
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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.
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Baseline, Day 30 of the intervention, Day 60 of the intervention;
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Change in Depressive Symptoms
Time Frame: Baseline, Day 30 of the intervention, Day 60 of the intervention;
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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.
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Baseline, Day 30 of the intervention, Day 60 of the intervention;
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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
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Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention
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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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Patient's Satisfaction: 8-item tDCS User Survey
Time Frame: Day 60 of the intervention
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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.
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Day 60 of the intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helena Knotkova, PhD, MJHS Institute for Innovation in Palliative Care (MJHSPalliative)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19008-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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