NCT02122237

Brief Summary

Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

November 4, 2013

Last Update Submit

May 27, 2015

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

  • Migraine frequency

    The investigators evaluate migraine frequency at baseline, 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

  • Scores at psychological scales

    6 months

Study Arms (1)

Cathodal Cefaly tDCS

EXPERIMENTAL

Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, everyday for 2 months, in 14 patients. The anode is placed over the left DLPFC.

Device: Cefaly tDCS

Interventions

Cefaly tDCSDEVICE

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

Cathodal Cefaly tDCS

Eligibility Criteria

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

You may qualify if:

  • diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

You may not qualify if:

  • 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, Belgium, 4000, Belgium

Location

Study Officials

  • Delphine Magis, MD,PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

  • Jean Schoenen, MD,PhD

    University of Liege

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Full Professor

Study Record Dates

First Submitted

November 4, 2013

First Posted

April 24, 2014

Study Start

September 1, 2013

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

BE(1)