RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Sep 2013
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 18, 2020
August 1, 2020
7 months
November 4, 2013
August 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of migraine
The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.
12 months
Secondary Outcomes (4)
Intensity of migraine
12 months
Acute medication intake
12 months
Attack duration
12 months
Scores on psychological scales
12 months
Study Arms (2)
Super Rapid Magstim Stimulator rTMS QP
ACTIVE COMPARATORrTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients
Placebo
PLACEBO COMPARATORrTMS 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse.
You may not qualify if:
- other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roberta Baschi
Liège, 4000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Schoenen, HP
University of Liege
- PRINCIPAL INVESTIGATOR
Delphine Magis, MD,PhD
University of Liege
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Full Professor
Study Record Dates
First Submitted
November 4, 2013
First Posted
April 25, 2014
Study Start
September 1, 2013
Primary Completion
April 1, 2014
Study Completion
September 1, 2014
Last Updated
August 18, 2020
Record last verified: 2020-08