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Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

NCT02168764 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-06-26

No results posted yet for this study

Summary

The primary objective of the study is to demonstrate the safety and efficacy of SPG stimulation with the ATI Neurostimulation System when used to treat acute cluster attacks in chronic cluster headache patients.

Conditions

  • Chronic Cluster Headache

Interventions

DEVICE

ATI Neurostimulation System

All subjects will be implanted with the ATI Neurostimulator which, along with the ATI Remote Controller, provides electrical stimulation.

Sponsors & Collaborators

  • Autonomic Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter J Goadsby, MD, PhD · UCSF Medical Center, Headache Center

  • David W Dodick, MD · Mayo Clinic, Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-03-31
Completion
2020-03-31

Countries

  • United States

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 NCT02168764 on ClinicalTrials.gov