A Study of Home-Delivered Neurostimulation for Migraine

NCT03874351 | Completed Results FDA Device

• 1 other identifier: 19008-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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 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

Keywords

Migraine;; transcranial direct current stimulation (tDCS); tDCS-Telehealth intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of Responders

  Day 60 of the intervention

• Migraine Attack Frequency

  Baseline, Day 30 of the intervention, Day 60 of the intervention

• Acute Medication Use

  Baseline, Day 30 of the intervention, Day 60 of the intervention

• Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period

  Baseline, Day 30 of the intervention, Day 60 of the intervention;

• Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)

  Baseline, Day 30 of the intervention, Day 60 of the intervention;

Study Arms (2)

Active tDCS

EXPERIMENTAL

Twenty minutes of direct current at intensity of 1.5 milliamperes (mA).

Device: non-invasive transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Thirty seconds of direct current at 1.5 mA, followed by 0 mA for the remaining time of the 20-minute stimulation period.

Device: non-invasive transcranial direct current stimulation (tDCS)

Interventions

non-invasive transcranial direct current stimulation (tDCS) DEVICE

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.

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MJHS Institute for Innovation in Palliative Care: lead
• New York Headache Center: collaborator

Study Sites (2)

MJHS Institute for Innovation in Palliative Care

New York, New York, 10006, United States

Location

New York Headache Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Helena Knotkova, PhD, PhilD
• Organization: MJHS Institute for Innovation in Palliative Care, New York, NY

HKnotkov@mjhs.org

646-784-2262

Study Officials

• Helena Knotkova, PhD

  MJHS Institute for Innovation in Palliative Care (MJHSPalliative)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: April 22, 2019
• Primary Completion: April 13, 2020
• Study Completion: May 12, 2020
• Last Updated: December 17, 2021
• Results First Posted: December 2, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)