NCT02122757

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

November 4, 2013

Last Update Submit

August 15, 2020

Conditions

Sporadic Migraine

Outcome Measures

Primary Outcomes (1)

  • Migraine frequency

    The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.

    6 months

Secondary Outcomes (4)

  • Migraine intensity

    6 months

  • Acute medication intake

    6 months

  • Attack duration

    6 months

  • Score on psychological scales

    6 Months

Study Arms (2)

Sham Anodal Cefaly tDCS

PLACEBO COMPARATOR

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

Device: sham Cefaly tDCS

Anodal Cefaly tDCS

ACTIVE COMPARATOR

2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients.

Device: Cefaly tDCS

Interventions

Cefaly tDCSDEVICE

Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.

Anodal Cefaly tDCS
sham Cefaly tDCSDEVICE

2mA during 30sec

Sham Anodal Cefaly tDCS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of episodic migraine with (ICHD III beta 1.2.1) or without aura (ICHD III beta 1.1)

You may not qualify if:

  • preventive treatment
  • others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberta Baschi

Liège, 4000, Belgium

Location

Study Officials

  • Delphine Magis, MD,PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

  • Jean Schoenen, MD,PhD

    University of Liege

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Full Professor

Study Record Dates

First Submitted

November 4, 2013

First Posted

April 25, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

BE(1)