Migraine Disorders Clinical Trial
Official title:
A Randomized Sham-Controlled Study of Home-Delivered Non-Invasive Neurostimulation for Migraine
NCT number | NCT03874351 |
Other study ID # | 19008-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 22, 2019 |
Est. completion date | May 12, 2020 |
Verified date | December 2021 |
Source | MJHS Institute for Innovation in Palliative Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 12, 2020 |
Est. primary completion date | April 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | MJHS Institute for Innovation in Palliative Care | New York | New York |
United States | New York Headache Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
MJHS Institute for Innovation in Palliative Care | New York Headache Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point); | |
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 | Day 60 of the intervention | |
Secondary | Migraine Attack Frequency | 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 | |
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. | 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. | 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. | 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. | Baseline, Day 30 of the intervention, Day 60 of the intervention; | |
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 | from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application | |
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. | Day 60 of the intervention |
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