Cephalic Vascular Recording Upon SPG Stimulation

Chronic Cluster Headache Clinical Trial

Official title:

Cephalic Vascular Recording Upon SPG Stimulation in CH Patients - Amendment to the Pathway CH-1 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359631
• Other study ID #: CIP-001-A
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: May 13, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Autonomic Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial Summary

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.

Description:

Efferent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Autonomic Technologies, Inc.