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Pathway CH-1 Long-Term Follow-Up

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Autonomic Technologies, Inc. Identifier:
First received: June 7, 2012
Last updated: March 8, 2016
Last verified: March 2016
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.

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 ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.

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 identifier: NCT01616511

Headache Research Unit. University Department of Neurology, Citadelle Hospital
Liege, Belgium, B-4000
Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
Glostrup, Copenhagen, Denmark, DK-2600
Headache Center, Dept. of Neurology, University Duisburg-Essen
Essen, Germany, 45147
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246
Servicio de Neurologia, Hospital Clinico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
Autonomic Technologies, Inc.
Principal Investigator: Jean Schoenen, MD, PhD Citadelle Hospital
  More Information

Responsible Party: Autonomic Technologies, Inc. Identifier: NCT01616511     History of Changes
Other Study ID Numbers: CP-005 
Study First Received: June 7, 2012
Last Updated: March 8, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Cluster Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases processed this record on October 25, 2016