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Pathway CH-1 Long-Term Follow-Up

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01616511
First received: June 7, 2012
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.

Condition
Chronic Cluster Headache

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects. [ Time Frame: Long-Term ]

Enrollment: 33
Study Start Date: June 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pathway CH-1 Subjects

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial, who have completed the Pathway CH-1 trial, and who remain implanted with an ATI Neurostimulator.
Criteria

Inclusion Criteria:

  • Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
  • Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
  • 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 or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
  • Subject is not suitable for the study for any reason in the judgment 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: NCT01616511

Locations
Belgium
Headache Research Unit. University Department of Neurology, Citadelle Hospital
Liege, Belgium, B-4000
Denmark
Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
Glostrup, Copenhagen, Denmark, DK-2600
Spain
Servicio de Neurologia, Hospital Clinico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
Principal Investigator: Jean Schoenen, MD, PhD Citadelle Hospital
  More Information

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01616511     History of Changes
Other Study ID Numbers: CP-005
Study First Received: June 7, 2012
Last Updated: January 5, 2017

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

ClinicalTrials.gov processed this record on July 19, 2017