Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

Status: Unknown status
Location: See all (24) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: No
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• Age from ≥22 years old.

• Subject has been diagnosed with chronic cluster headache according to the 2013 ICHD, 3rd edition (beta version), criterion 3.1.2.

• Subject reports a minimum of 4 cluster attacks per week on the side of their dominant headache laterality. Subjects who report more than 8 attacks per day or attack duration of less than 30 minutes (untreated or unsuccessfully treated) must have been tested to rule out other forms of trigeminal autonomic cephalalgias.

• Both subject and physician judge previously or currently used preventive and/or acute cluster headache treatment to be inadequate.

• Subject is able to distinguish cluster attacks from other headaches (i.e., migraine, tension-type headaches).

• Subject agrees to not use therapy involving TENS or magnetic field treatment while the Neurostimulator is implanted.

• Subject agrees to not participate in supplemental or alternative therapy, including acupuncture and spinal manipulation, from Study Enrollment through the end of the Experimental Period of the study.

• Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) - except to manage tolerability - from Study Enrollment through the Experimental Period of the study.

• Subject agrees not to use any acute medications, including oxygen therapy, for their treatable cluster attacks during the Experimental Period until after they have used SPG stimulation therapy for at least 15 minutes.

• Subject has had a dental examination and cleaning in the past six (6) months.

• Subject has the ability to read and comprehend, and to reliably record information as required by the Protocol.

• Subject is able to provide written informed consent prior to participation in the study.

Locations
United States
Arizona
Mayo Clinic
Phoenix
California
University of Southern California
Los Angeles
Stanford University
Stanford
Connecticut
Yale University
New Haven
New England Institute for Clinical Research
Stamford
Illinois
Diamond Headache Clinic
Chicago
University of Chicago, Illinois - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER
Chicago
Robbins Headache Clinic
Northbrook
Kentucky
Norton Neurology Services
Louisville
Massachusetts
New England Regional Headache Center
Worcester
Michigan
Michigan Headache and Neurological Institute
Ann Arbor
Missouri
Mercy Health Research
Saint Louis
Headache Care Center (Springfield)
Springfield
North Carolina
Carolina Headache Institute
Durham
New Hampshire
Dartmouth Hitchcock-Medical Center
Lebanon
Nevada
Nevada Headache Institute
Las Vegas
New York
Dent Neurosciences Research Institute
Amherst
Lenox Hill Hospital, The New York Head and Neck Institute - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER
New York
Mount Sinai Hospital
New York
Island Neurological Association
Plainview
Ohio
The Ohio State University Wexner Medical Center
Columbus
Pennsylvania
Jefferson Headache Center, Thomas Jefferson University
Philadelphia
Texas
University of Texas, Southwestern
Dallas
Virginia
Inova Medical Group Neurology and Headache
Falls Church
Time Frame
Start Date: July 2014
Completion Date: March 2020
Participants
Target number of participants: 120
Treatments
Experimental: Treatment
Both arms of the study receive the ATI Neurostimulation System. Subjects are implanted with the ATI Neurostimulator and instructed to use the ATI Remote Controller to treat cluster attacks of at least moderate intensity by stimulating for 15 minutes before using any acute medications.
Active Comparator: Control
Both arms of the study receive the ATI Neurostimulation System. Subjects are implanted with the ATI Neurostimulator and instructed to use the ATI Remote Controller to treat cluster attacks of at least moderate intensity by stimulating for 15 minutes before using any acute medications.
Related Therapeutic Areas
Sponsors
Leads: Autonomic Technologies, Inc.

This content was sourced from clinicaltrials.gov

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