Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine (Medis)

Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine

The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.

Study Overview

• Status: Completed
• Conditions: Chronic Migraine as Defined by Criteria of International Headache Society (IHS)
• Intervention / Treatment: Device: Transcranial direct current stimulation of the motor cortex; Device: simulation of Transcranial direct current stimulation of the motor cortex

Detailed Description

Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).

Patients will have 5 evaluation examinations:

• The first, one before tDCS,
• The second, 1 month after the beginning of tDCS
• The third, immediately after the end of tDCS
• The fourth, 1 month after the end of tDCS
• And the last one, 3 months after the end of tDCS.

The physician responsible for conducting tDCS sessions will make the randomization via a website.

The physician in charge of the evaluation examinations will don't know the allocated treatment.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Isere
    • Grenoble, Isere, France, 38043
      • Grenoble University Hospital
    • Voiron, Isere, France, 38500
      • Hospital of Voiron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of chronic migraine for more than 1 year
• Stable treatment since 1 month
• Frequency of migraine crisis is above 8 per month during last month
• chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
• Patient agreeing not to try other migraine prophylactic treatment, throughout the study
• Patient's written consent

Exclusion Criteria:

• History of drug addiction, epilepsy, or severe head trauma with bone break
• History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
• Presence of intracranial ferromagnetic material or an implanted stimulator
• Introduction of a new treatment for less than a month
• Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
• Person not understanding the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS	Device: Transcranial direct current stimulation of the motor cortex; The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp. Stimulation parameters: 2 mA intensity; Continuous stimulation for 20 min with rise times and fall times of 10 seconds each
Placebo Comparator: simulated tDCS	Device: simulation of Transcranial direct current stimulation of the motor cortex; The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp. Stimulation parameters: The intensity of the stimulation current is 2 mA; The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of the evolution of seizure frequency between the two groups	Evolution of seizure frequency since base line to 3 months after the end of tDCS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the evolution of seizure severity between the two groups	Headache Impact Test 6 (HIT-6) questionnaire	Evolution of seizure severity since base line to 3 months after the end of tDCS
Comparison of the evolution of crisis treatment use between the two groups	Frequency of taking crisis treatment. After each crisis, taking crisis treatment will be noted by the patient on his migraine record book.	Evolution of crisis treatment use since base line until 3 months after the end of tDCS
Comparison of the evolution of the disease impact between the two groups	Migraine Disability Assessment Scale (MIDAS) scale	Evolution of the disease impact since base line to 3 months after the end of tDCS
Comparison of the evolution of the patient satisfaction between the two groups	Clinical Global Impression (CGI) scale	Evolution of the patient satisfaction since base line to 3 months after the end of tDCS
Comparison of the evolution of the quality of life between the two groups	Short Form 12 (SF-12) quality of life questionnaire	Evolution of the quality of life since base line until 3 months after the end of tDCS
Comparison of the evolution of anxiety and depression levels between the two groups	Hospital Anxiety and Depression scale (HAD) questionnaire	Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: HODAJ Hasan, MD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2014
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Chronic migraine, tDCS, Transcranial direct current stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: DCIC13/48