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Cephalic Vascular Recording Upon SPG Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359631
First Posted: May 25, 2011
Last Update Posted: May 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Autonomic Technologies, Inc.
  Purpose

Hypothesis:

Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter.

Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel diameter.


Condition
Chronic Cluster Headache

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cephalic Vascular Recording Upon SPG Stimulation in CH Patients - Amendment to the Pathway CH-1 Trial

Resource links provided by NLM:


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

Enrollment: 7
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:
Efferent
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

Inclusion Criteria:

•Subject is currently enrolled in Pathway CH-1 (CIP-001)

Exclusion Criteria:

•Subject is NOT currently enrolled in Pathway CH-1(CIP-001)

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Henrik Schytz, MD, Human Migraine Research Lab, Dep. Neurology, Glostrup Hospital
ClinicalTrials.gov Identifier: NCT01359631     History of Changes
Other Study ID Numbers: CIP-001-A
First Submitted: May 23, 2011
First Posted: May 25, 2011
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Autonomic Technologies, Inc.:
Chronic Cluster Headache

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