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Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

NCT01255813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-12-29

No results posted yet for this study

Summary

The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.

Conditions

  • Chronic Cluster Headache

Interventions

DEVICE

Stimulation (Sub-perception)

Stimulation applied below the perception threshold

DEVICE

Stimulation (Full)

Stimulation applied above the perception threshold

OTHER

Control

No stimulation applied

Sponsors & Collaborators

  • Autonomic Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Jean Schoenen, M.D. · Professor of Functional Neuroanatomy, Leige University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Belgium
  • Denmark
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01255813 on ClinicalTrials.gov