Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 60
Inclusion Criteria
- Stable treatment since 1 month
- chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- Patient's written consent
- ...
- Stable treatment since 1 month
- chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- Patient's written consent
- Diagnosis of chronic migraine for more than 1 year
- Frequency of migraine crisis is above 8 per month during last month
- Patient agreeing not to try other migraine prophylactic treatment, throughout the study
Exclusion Criteria
- Person not understanding the study protocol
- Presence of intracranial ferromagnetic material or an implanted stimulator
- History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- ...
- Person not understanding the study protocol
- Presence of intracranial ferromagnetic material or an implanted stimulator
- History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- Introduction of a new treatment for less than a month
- History of drug addiction, epilepsy, or severe head trauma with bone break
- Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
Summary
- Conditions
- Chronic Migraine as Defined by Criteria of International Headache Society (IHS)
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 da...
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.
Inclusion Criteria
- Stable treatment since 1 month
- chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- Patient's written consent
- ...
- Stable treatment since 1 month
- chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- Patient's written consent
- Diagnosis of chronic migraine for more than 1 year
- Frequency of migraine crisis is above 8 per month during last month
- Patient agreeing not to try other migraine prophylactic treatment, throughout the study
Exclusion Criteria
- Person not understanding the study protocol
- Presence of intracranial ferromagnetic material or an implanted stimulator
- History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- ...
- Person not understanding the study protocol
- Presence of intracranial ferromagnetic material or an implanted stimulator
- History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- Introduction of a new treatment for less than a month
- History of drug addiction, epilepsy, or severe head trauma with bone break
- Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
Tracking Information
- NCT #
- NCT02120326
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: HODAJ Hasan, MD University Hospital, Grenoble
- HODAJ Hasan, MD University Hospital, Grenoble