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

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ClinicalTrials.gov Identifier: NCT02122744
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, 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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: Super Rapid Magstim Stimulator Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: 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
Device: 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.


Placebo Comparator: 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.



Primary Outcome Measures :
  1. Frequency of migraine [ Time Frame: 12 months ]
    The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.


Secondary Outcome Measures :
  1. Intensity of migraine [ Time Frame: 12 months ]
    The investigators evaluate the intensity of migraine during the treatment and 2 months after its end

  2. Acute medication intake [ Time Frame: 12 months ]
    The investigators evaluate acute medication intake during the treatment and 2 months after its end

  3. Attack duration [ Time Frame: 12 months ]
    The investigators evaluate attack duration during the treatment and 2 months after its end

  4. Scores on psychological scales [ Time Frame: 12 months ]
    The investigators evaluate scores on psychological scales during the treatment and 2 months after its end



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122744


Locations
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Belgium
Roberta Baschi
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Jean Schoenen, HP University of Liège
Principal Investigator: Delphine Magis, MD,PhD University of Liège

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Responsible Party: Jean Schoenen, Honorary Full Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02122744     History of Changes
Other Study ID Numbers: CB-1331
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases