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

Chronic Migraine Clinical Trial

Official title:

Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02122744
• Other study ID #: CB-1331
• Status: Withdrawn
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

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.
• Super Rapid Magstim Stimulator (sham)
coil perpendicular to the scalp

Locations

Country	Name	City	State
Belgium	Roberta Baschi	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of migraine	The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.	12 months
Secondary	Intensity of migraine	The investigators evaluate the intensity of migraine during the treatment and 2 months after its end	12 months
Secondary	Acute medication intake	The investigators evaluate acute medication intake during the treatment and 2 months after its end	12 months
Secondary	Attack duration	The investigators evaluate attack duration during the treatment and 2 months after its end	12 months
Secondary	Scores on psychological scales	The investigators evaluate scores on psychological scales during the treatment and 2 months after its end	12 months