Randomised Sham-controlled Trial of Anodal Transcranial Direct Current Stimulation (tDCS) for the Prevention of Episodic Migraine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Liege
- Locations
- 1
- Primary Endpoint
- Migraine frequency
Study Overview
Brief Summary
Anodal tDCS increases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in episodic migraine.
Detailed Description
During the interictal phase, the cerebral cortex is characterised by hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical evoked responses. Such habituation deficit can be shown in the visual cortex by the study of visual evoked potentials (VEP) and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. In healthy subjects and in migraineurs between attacks, anodal tDCS increases VEP habituation and 1st block amplitude. In a proof-of-concept trial, the investigators have shown in 10 episodic migraine without aura patients that 2 weekly 15-minute sessions for 8 weeks of anodal tDCS over the visual cortex significantly decreased attack frequency, migraine days, attack duration and acute medication intake for more than 4 weeks after the last treatment session.
This randomized trial was designed to prove the preventive effect in episodic migraine of anodal tDCS over the visual cortex compared to sham stimulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of episodic migraine with (ICHD III beta 1.2.1) or without aura (ICHD III beta 1.1)
Exclusion Criteria
- •preventive treatment
- •others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)
Arms & Interventions
Sham Anodal Cefaly tDCS
2 mA placebo anodal tDCS (the direct current is delivered just for 30 seconds) is applied over the visual cortex for 20 minutes, everyday for 2 months, in 15 patients
Intervention: sham Cefaly tDCS (Device)
Anodal Cefaly tDCS
2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients.
Intervention: Cefaly tDCS (Device)
Outcomes
Primary Outcomes
Migraine frequency
Time Frame: 6 months
The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.
Secondary Outcomes
- Attack duration(6 months)
- Acute medication intake(6 months)
- Migraine intensity(6 months)
- Score on psychological scales(6 Months)
Investigators
Jean Schoenen
Honorary Full Professor
University of Liege