Status:
COMPLETED
A Study of Home-Delivered Neurostimulation for Migraine
Lead Sponsor:
MJHS Institute for Innovation in Palliative Care
Collaborating Sponsors:
New York Headache Center
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
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 symp...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03874351
Start Date
April 22 2019
End Date
May 12 2020
Last Update
December 17 2021
Active Locations (2)
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1
MJHS Institute for Innovation in Palliative Care
New York, New York, United States, 10006
2
New York Headache Center
New York, New York, United States, 10021