NCT02440776

Brief Summary

Monitor the safety and performance of the Pulsante Microstimulator System.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
5 countries

9 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

May 6, 2015

Last Update Submit

June 25, 2018

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • Characterization of all device/procedure related Adverse Events

    Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.

    Through five years post implant

Secondary Outcomes (1)

  • Acute response to therapy

    Through five years post implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System

You may qualify if:

  • Patient meets CE marked labeling for cluster headache.
  • Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
  • Patient is able to provide written informed consent prior to participation in the study.

You may not qualify if:

  • \. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rigshospitalet Neurocenter

Glostrup Municipality, 2600, Denmark

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie

Dresden, 01307, Germany

Location

Heinrich-Heine-University

Düsseldorf, D-40225, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29

Kassel, 34121, Germany

Location

Neurologie + Kopfschmerzzentrum Münchner Freiheit

Munich, 80802, Germany

Location

Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna

Stockholm, 17176, Sweden

Location

University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26

Zurich, 8091, Switzerland

Location

The Walton Center

Liverpool, L97LJ, United Kingdom

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 12, 2015

Study Start

April 1, 2015

Primary Completion

May 13, 2018

Study Completion

June 30, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

CH(1)DE(5)DK(1)GB(1)SE(1)