Back to results

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

Primary Purpose

Chronic Migraine as Defined by Criteria of International Headache Society (IHS)

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Transcranial direct current stimulation of the motor cortex

simulation of Transcranial direct current stimulation of the motor cortex

About this trial

This is an interventional treatment trial for Chronic Migraine as Defined by Criteria of International Headache Society (IHS) focused on measuring Chronic migraine, tDCS, Transcranial direct current stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Grenoble University Hospital
Hospital of Voiron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active tDCS

simulated tDCS

Arm Description

Outcomes

Primary Outcome Measures

Comparison of the evolution of seizure frequency between the two groups

Secondary Outcome Measures

Comparison of the evolution of seizure severity between the two groups

Headache Impact Test 6 (HIT-6) questionnaire

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.

Comparison of the evolution of the disease impact between the two groups

Migraine Disability Assessment Scale (MIDAS) scale

Comparison of the evolution of the patient satisfaction between the two groups

Clinical Global Impression (CGI) scale

Comparison of the evolution of the quality of life between the two groups

Short Form 12 (SF-12) quality of life questionnaire

Comparison of the evolution of anxiety and depression levels between the two groups

Hospital Anxiety and Depression scale (HAD) questionnaire

Full Information

NCT ID

NCT02120326

First Posted

April 15, 2014

Last Updated

November 3, 2020

Sponsor

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT02120326

Brief Title

Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine

Acronym

Medis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

May 5, 2014 (Actual)

Primary Completion Date

December 18, 2019 (Actual)

Study Completion Date

June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Migraine as Defined by Criteria of International Headache Society (IHS)

Keywords

Chronic migraine, tDCS, Transcranial direct current stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

active tDCS

Arm Type

Experimental

Arm Title

simulated tDCS

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation of the motor cortex

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

simulation of Transcranial direct current stimulation of the motor cortex

Intervention Description

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.

Primary Outcome Measure Information:

Title

Comparison of the evolution of seizure frequency between the two groups

Time Frame

Evolution of seizure frequency since base line to 3 months after the end of tDCS

Secondary Outcome Measure Information:

Title

Comparison of the evolution of seizure severity between the two groups

Description

Headache Impact Test 6 (HIT-6) questionnaire

Time Frame

Evolution of seizure severity since base line to 3 months after the end of tDCS

Title

Comparison of the evolution of crisis treatment use between the two groups

Description

Frequency of taking crisis treatment. After each crisis, taking crisis treatment will be noted by the patient on his migraine record book.

Time Frame

Evolution of crisis treatment use since base line until 3 months after the end of tDCS

Title

Comparison of the evolution of the disease impact between the two groups

Description

Migraine Disability Assessment Scale (MIDAS) scale

Time Frame

Evolution of the disease impact since base line to 3 months after the end of tDCS

Title

Comparison of the evolution of the patient satisfaction between the two groups

Description

Clinical Global Impression (CGI) scale

Time Frame

Evolution of the patient satisfaction since base line to 3 months after the end of tDCS

Title

Comparison of the evolution of the quality of life between the two groups

Description

Short Form 12 (SF-12) quality of life questionnaire

Time Frame

Evolution of the quality of life since base line until 3 months after the end of tDCS

Title

Comparison of the evolution of anxiety and depression levels between the two groups

Description

Hospital Anxiety and Depression scale (HAD) questionnaire

Time Frame

Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HODAJ Hasan, MD

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grenoble University Hospital

City

Grenoble

State/Province

Isere

ZIP/Postal Code

38043

Country

France

Facility Name

Hospital of Voiron

City

Voiron

State/Province

Isere

ZIP/Postal Code

38500

Country

France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine

We'll reach out to this number within 24 hrs