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Completed

NCT Number: NCT01616511

Pathway CH-1 Long-Term Follow-Up

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.

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Key information

Conditions

Chronic Cluster Headache Brain Diseases Central Nervous System Diseases Cluster Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Sex eligibility

All sexes

Study type

Observational

Primary location

Headache Research Unit. University Department of Neurology, Citadelle Hospital, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Autonomic Technologies, Inc.

Industry

Registry information

Official study title

Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2012
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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