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

NCT ID: NCT02122744

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Super Rapid Magstim Stimulator rTMS QP

rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients

Group Type ACTIVE_COMPARATOR

Super Rapid Magstim Stimulator

Intervention Type DEVICE

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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Super Rapid Magstim Stimulator (sham)

Intervention Type DEVICE

coil perpendicular to the scalp

Interventions

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Super Rapid Magstim Stimulator

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

Super Rapid Magstim Stimulator (sham)

coil perpendicular to the scalp

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean Schoenen

Honorary Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Schoenen, HP

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Delphine Magis, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

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Roberta Baschi

Liège, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CB-1331

Identifier Type: -

Identifier Source: org_study_id

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