MedTrace Logo

A Study of Home-Delivered Neurostimulation for Migraine

NCT03874351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-12-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Migraine Disorders

Interventions

DEVICE

non-invasive transcranial direct current stimulation (tDCS)

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.

Sponsors & Collaborators

  • New York Headache Center

    collaborator OTHER

  • MJHS Institute for Innovation in Palliative Care

    lead OTHER

Principal Investigators

  • Helena Knotkova, PhD · MJHS Institute for Innovation in Palliative Care (MJHSPalliative)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-04-13
Completion
2020-05-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874351 on ClinicalTrials.gov