Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

NCT ID: NCT02227758

Last Updated: 2019-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

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.

The purpose of this study is to evaluate the long-term safety and performance of neurostimulation for the treatment of intractable chronic migraine as well as to detect infrequent complications or problems only apparent in "real-world" practice

Detailed Description

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

Conditions

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

Intractable Chronic Migraine

Study Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

implanted chronic migraine patients

Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system

No interventions assigned to this group

Eligibility Criteria

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

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Locations

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

Heilig Hartziekenhuis

Roeselare, West-Vlaanderen, Belgium

Site Status

Centre Hospitalier Régional de la CITADELLE

Liège, , Belgium

Site Status

Klinikum Delmenhorst GmbH

Delmenhorst, Großherzogtum Oldenburg, Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Praxis fur Neurologie, Spezielle Schmerztherapie, Psychotherapie

Essen, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Migräne and Kopfschmerzklinik Königstein

Königstein, Saxony, Germany

Site Status

Schmerzklinik und Praxis an der Schmerzklinik Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Neurologische Klinik und Poliklinik Charité Campus Mitte

Berlin, , Germany

Site Status

Centre Hospitalier de Luxembourg

Luxembourg, , Luxembourg

Site Status

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Site Status

Hospital Universitario

Madrid, , Spain

Site Status

Hospital Puerta de Hierro

Madrid, , Spain

Site Status

Karolinska Hospital

Stockholm, Stockholm County, Sweden

Site Status

John Radcliffe hospital

Oxford, Oxfordshire, United Kingdom

Site Status

Royal London Hospital

London, Royal London Hospital, United Kingdom

Site Status

Seacroft Hospital

Leeds, Yorkshire, United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Countries

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

Belgium Germany Luxembourg Spain Sweden United Kingdom

Other Identifiers

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

NM-11-059-EU-ON

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Botox Injection in Treatment of Chronic Migraine
NCT02259075 COMPLETED PHASE1/PHASE2