Cephalic Vascular Recording Upon SPG Stimulation

This study has been completed.

Sponsor:

Information provided by:

Autonomic Technologies, Inc.

ClinicalTrials.gov Identifier:

NCT01359631

First received: May 23, 2011

Last updated: May 13, 2012

Last verified: May 2012

History of Changes

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:

MedlinePlus related topics: Headache

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

No publications provided

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
Study First Received:	May 23, 2011
Last Updated:	May 13, 2012
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Autonomic Technologies, Inc.:

Chronic Cluster Headache

Additional relevant MeSH terms:

Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cluster Headache

Headache
Trigeminal Autonomic Cephalalgias
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

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