NCT01359631

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

May 23, 2011

Last Update Submit

May 13, 2012

Conditions

Chronic Cluster Headache

Keywords

Chronic Cluster Headache

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05