A Study of Home-Delivered Neurostimulation for Migraine
Completed · Not applicable · Has a placebo group
Conditions studied: Migraine Disorders
In brief
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.
Key facts
- Study ID
- NCT03874351
- Run by
- MJHS Institute for Innovation in Palliative Care
- People needed
- 22
- Starts
- 2019-04-22
- Expected to finish
- 2020-05-12
- Last updated by the study team
- 2021-12-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- MJHS Institute for Innovation in Palliative Care — New York, New York, United States
- New York Headache Center — New York, New York, United States
Full record on ClinicalTrials.gov
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