RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine

Not Applicable

Withdrawn

• Conditions: Chronic Migraine
• Interventions: Device: Super Rapid Magstim Stimulator (sham); Device: Super Rapid Magstim Stimulator

• Registration Number: NCT02122744
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-04
• Primary Completion: 2014-04
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-25
• Study Completion: 2014-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-15
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Super Rapid Magstim Stimulator (sham)	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.
Super Rapid Magstim Stimulator rTMS QP	Super Rapid Magstim Stimulator	rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients

Primary Outcome Measures

Name	Time	Method
Frequency of migraine	12 months	The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.

Secondary Outcome Measures

Name	Time	Method
Intensity of migraine	12 months	The investigators evaluate the intensity of migraine during the treatment and 2 months after its end
Attack duration	12 months	The investigators evaluate attack duration during the treatment and 2 months after its end
Acute medication intake	12 months	The investigators evaluate acute medication intake during the treatment and 2 months after its end
Scores on psychological scales	12 months	The investigators evaluate scores on psychological scales during the treatment and 2 months after its end

Trial Locations

Locations (1)

Roberta Baschi; 🇧🇪 Liège, Belgium