Occipital Transcutaneous Stimulation in Chronic Migraine

NCT ID: NCT02307071

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic migraine is a disabling neurological condition affecting 0.5-2% of the population.

CM is difficult to treat and preventive treatment options are limited. Due to the inefficiency of available and the lack of new preventive anti-migraine drug, neurostimulation methods have raised great interest in recent years.

The ONSTIM study showed a reduction in headache frequency in 39% of patients treated with active ONS during 12 weeks, compared to no improvement in the "non-effectively" stimulated or medically treated groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cefaly Kit Arnold

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.

Group Type EXPERIMENTAL

Cefaly Kit Arnold

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cefaly Kit Arnold

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* other diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Liege

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jean Schoenen

Honorary Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Schoenen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Delphine Magis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHR Citadelle

Liège, Belgium, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna Cosseddu, MD

Role: CONTACT

+3242256925

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna Cosseddu, MD

Role: primary

+3242256925

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OTSCM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TCDS for the Treatment of Chronic Migraine
NCT07214454 NOT_YET_RECRUITING NA
Occipital Nerve Stimulation in Chronic Migraine
NCT07087678 NOT_YET_RECRUITING NA