Back to resultsRCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
Primary Purpose
Chronic Migraine
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Super Rapid Magstim Stimulator
Super Rapid Magstim Stimulator (sham)
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
- diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse.
Exclusion Criteria:
- other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
Sites / Locations
- Roberta Baschi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Super Rapid Magstim Stimulator rTMS QP
Placebo
Arm Description
rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients
rTMS QP placebo (coil perpendicular to the scalp) is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients.
Outcomes
Primary Outcome Measures
Frequency of migraine
The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.
Secondary Outcome Measures
Intensity of migraine
The investigators evaluate the intensity of migraine during the treatment and 2 months after its end
Acute medication intake
The investigators evaluate acute medication intake during the treatment and 2 months after its end
Attack duration
The investigators evaluate attack duration during the treatment and 2 months after its end
Scores on psychological scales
The investigators evaluate scores on psychological scales during the treatment and 2 months after its end
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02122744
Brief Title
RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
Official Title
Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.
Detailed Description
The investigators have already inquired if inhibiting rTMS QP over the visual cortex determines a reduction of frequency of migraine in a previous study. After 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. In this study, the investigators aim to compare rTMS QP effect with the placebo effect and to evaluate if rTMS QP is capable to induce changes in VEP, CHEPS and QST.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Super Rapid Magstim Stimulator rTMS QP
Arm Type
Active Comparator
Arm Description
rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
rTMS QP placebo (coil perpendicular to the scalp) is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients.
Intervention Type
Device
Intervention Name(s)
Super Rapid Magstim Stimulator
Intervention Description
The repetitive transcranial magnetic stimulation (rTMS) is able to modify cortical excitability and reactivity. 1Hz rTMS inhibits the cortex, 10Hz excites it. In particular, a new paradigm of rTMS, the rTMS quadri pulse has a more lasting and effective activity.
The side effects are rare and transient: migraine,contractions of the muscles of the neck due to muscle stimulation by the electromagnetic field of the coil.
Intervention Type
Device
Intervention Name(s)
Super Rapid Magstim Stimulator (sham)
Intervention Description
coil perpendicular to the scalp
Primary Outcome Measure Information:
Title
Frequency of migraine
Description
The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Intensity of migraine
Description
The investigators evaluate the intensity of migraine during the treatment and 2 months after its end
Time Frame
12 months
Title
Acute medication intake
Description
The investigators evaluate acute medication intake during the treatment and 2 months after its end
Time Frame
12 months
Title
Attack duration
Description
The investigators evaluate attack duration during the treatment and 2 months after its end
Time Frame
12 months
Title
Scores on psychological scales
Description
The investigators evaluate scores on psychological scales during the treatment and 2 months after its end
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse.
Exclusion Criteria:
other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Schoenen, HP
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Delphine Magis, MD,PhD
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roberta Baschi
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
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