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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02122744
Enrollment
0
Registered
2014-04-25
Start date
2013-09-30
Completion date
2014-09-30
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine

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.

Interventions

DEVICESuper 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.

DEVICESuper Rapid Magstim Stimulator (sham)

coil perpendicular to the scalp

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Frequency of migraine12 monthsThe investigators evaluate the frequency of migraine during the treatment and 2 months after its end.

Secondary

MeasureTime frameDescription
Scores on psychological scales12 monthsThe investigators evaluate scores on psychological scales during the treatment and 2 months after its end
Intensity of migraine12 monthsThe investigators evaluate the intensity of migraine during the treatment and 2 months after its end
Acute medication intake12 monthsThe investigators evaluate acute medication intake during the treatment and 2 months after its end
Attack duration12 monthsThe investigators evaluate attack duration during the treatment and 2 months after its end

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026