← Back to Search

Neurostimulation

Treatment for 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

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.

Eligible Conditions
  • Cluster Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy
Primary Safety
Secondary outcome measures
Secondary Efficacy

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Michigan
Pennsylvania
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Michigan Headache and Neurological Institute
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried 4 different medications and still not much relief. Pain is unbearable.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
2014. "Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02168764.
All > Headache > Cluster Headache
~11 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top