NCT02307071

Brief Summary

This study evaluates the effect in chronic migraine patients of daily 20 minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

December 1, 2014

Last Update Submit

May 27, 2015

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

  • Monthly frequency of migraine days

    2 months treatment

Secondary Outcomes (4)

  • Monthly frequency of headache days

    2 months

  • Monthly frequency of total headache days

    2 months

  • Cumulative monthly headache hours

    2 months

  • Monthly acute drug intake

    2 months

Study Arms (1)

Cefaly Kit Arnold

EXPERIMENTAL

Occipital transcranial stimulation is implemented in occipital region at 16 mA of intensity, for 20 minutes, everyday for 3 months, in 20 chronic migraine patients.

Device: Cefaly Kit Arnold

Interventions

Cefaly Kit ArnoldDEVICE

Occipital neurostimulation can have a therapeutic effect in chronic migraine treatment, thus representing a possible therapeutic option in patients that do not respond to any medication.

Cefaly Kit Arnold

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:

  • other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Citadelle

Liège, Belgium, 4000, Belgium

RECRUITING

Study Officials

  • Jean Schoenen, MD, PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

  • Delphine Magis, MD, PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Cosseddu, MD

CONTACT

+3242256925cossedduanna@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
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

December 1, 2014

First Posted

December 3, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

BE(1)