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Neurostimulation
Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
N/A
Waitlist Available
Led By David W Dodick, MD
Research Sponsored by Autonomic Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post-implant
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Cluster Headache
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post-implant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy
Primary Safety
Secondary study objectives
Secondary Efficacy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATI Neurostimulation System
2012
N/A
~80
Find a Location
Who is running the clinical trial?
Autonomic Technologies, Inc.Lead Sponsor
7 Previous Clinical Trials
346 Total Patients Enrolled
5 Trials studying Cluster Headache
263 Patients Enrolled for Cluster Headache
David W Dodick, MDPrincipal InvestigatorMayo Clinic, Department of Neurology
2 Previous Clinical Trials
983 Total Patients Enrolled
Peter J Goadsby, MD, PhDPrincipal InvestigatorUCSF Medical Center, Headache Center