Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine

NCT ID: NCT02120326

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-05
• Study Completion Date: 2020-06-23

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active tDCS

Group Type: EXPERIMENTAL

Transcranial direct current stimulation of the motor cortex

Intervention Type: DEVICE

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

simulated tDCS

Group Type: PLACEBO_COMPARATOR

simulation of Transcranial direct current stimulation of the motor cortex

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HODAJ Hasan, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Grenoble University Hospital

Grenoble, Isere, France

Hospital of Voiron

Voiron, Isere, France

Countries

France

References

Hodaj H, Payen JF, Mick G, Vercueil L, Hodaj E, Dumolard A, Noelle B, Delon-Martin C, Lefaucheur JP. Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial. Brain Stimul. 2022 Mar-Apr;15(2):441-453. doi: 10.1016/j.brs.2022.02.012. Epub 2022 Feb 25.

Reference Type: RESULT

PMID: 35219923 (View on PubMed)

Other Identifiers

DCIC13/48

Identifier Type: -

Identifier Source: org_study_id