N/A
N=22
A Study of Home-Delivered Neurostimulation for Migraine
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03874351 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Migraine Days Per Month — -8; -4; -3; -3 migraine days per month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- non-invasive transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MJHS Institute for Innovation in Palliative Care
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Migraine Days Per Month |
-8; -4; -3; -3 | — |
| SECONDARY Percentage of Responders |
18.18; 36.36 | — |
| SECONDARY Migraine Attack Frequency |
-1; -2; 1; 0 | — |
| SECONDARY Acute Medication Use |
-1; -1; -2; -2 | — |
| SECONDARY Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period |
0; -1; -1; -1 | — |
| SECONDARY Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ) |
-11; -7; -12; -8 | — |
| SECONDARY Change in Depressive Symptoms |
-4; -2; -5; -3 | — |
| SECONDARY Tolerability of the Study Intervention: Number of Side Effects and Adverse Events |
3; 0 | — |
| SECONDARY Patient's Satisfaction: 8-item tDCS User Survey |
41; 57 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03874351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.