Chronic Migraine as Defined by Criteria of International Headache Society (IHS) Clinical Trial
— MedisOfficial title:
Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine
NCT number | NCT02120326 |
Other study ID # | DCIC13/48 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2014 |
Est. completion date | June 23, 2020 |
Verified date | November 2020 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 23, 2020 |
Est. primary completion date | December 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Grenoble University Hospital | Grenoble | Isere |
France | Hospital of Voiron | Voiron | Isere |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |