Trial record 11 of 13 for:    Open Studies | "Cluster Headache"

Pathway CH Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Autonomic Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01677026
First received: August 29, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

The primary objectives of the Registry are to:

  1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and
  2. Collect additional evidence to support reimbursement and clinical acceptance and long term follow up (two years)

Condition
Cluster Headache

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Resource links provided by NLM:


Further study details as provided by Autonomic Technologies, Inc.:

Primary Outcome Measures:
  • Major Device- and Surgical-Related Complications [ Time Frame: Through 6 months post-implant ] [ Designated as safety issue: Yes ]

    The occurrence rate of the following adverse events will be compared with occurrence rates in the literature:

    1. Death
    2. Any surgery or hospitalization due to deterioration in subject health
    3. Other Major Device-related Adverse Events


Secondary Outcome Measures:
  • Abortive [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]
    Percentage of headache attacks treated with SPG stimulation achieving Effective Therapy assessed during the 4 week Therapy Evaluation Period

  • Preventive [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]

    Percent change in headache frequency between the 4 week Therapy Evaluation Period and the 4 week Baseline Period;

    Percent change in headache frequency between the 4 week Therapy Evaluation Period and the first 4 weeks of the Post-Implant Stabilization Period


  • Responder Analysis [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]
    Percentage of subjects experiencing abortive effect, preventive effect or both

  • Disability and Quality of Life [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]
    Disability and Quality of Life as categorized by the HIT-6 and SF-36v2 surveys at the end of the Therapy Evaluation Period as compared to Baseline

  • Global Patient Evaluation of SPG Stimulation Therapy [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]
    Global patient evaluation of SPG stimulation therapy (very poor, poor, no opinion, good, very good) at the end of the Therapy Evaluation Period


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.

Criteria

Inclusion Criteria:

  • Subject meets CE marked labeling for cluster headache.
  • Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
  • Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
  • Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
  • Subject is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

  • Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.
  • Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
  • Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677026

Locations
Germany
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE) Recruiting
Hamburg, Germany, 20246
Contact: Arne May, MD, PhD       a.may@uke.de   
Principal Investigator: Arne May, MD, PhD         
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
Principal Investigator: Arne May, MD, PhD Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
  More Information

No publications provided

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01677026     History of Changes
Other Study ID Numbers: CP-004
Study First Received: August 29, 2012
Last Updated: October 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014