Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

Autonomic Technologies, Inc.24 sites in 1 country120 target enrollmentJuly 2014

ConditionsChronic Cluster Headache

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Cluster Headache
Sponsor: Autonomic Technologies, Inc.
Enrollment: 120
Locations: 24
Primary Endpoint: Primary Safety
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

March 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Autonomic Technologies, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anesthesia.
•Subject has had a change in type, dosage or dose frequency of preventive headache medications \< one (1) month prior to study enrollment
•Subject has been diagnosed with any other form of Trigeminal Autonomic Cephalalgias (e.g., paroxysmal hemicrania, SUNCT, etc.) or has a history of trigeminal neuralgia.
•Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site that, in the opinion of the Investigator, may lead to an inability to properly implant the Neurostimulator.
•Subject currently has an active oral or dental abscess or an active maxillary sinus infection based on present symptoms.
•Subject has been treated with therapeutic radiation to the facial region.
•Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
•Subject has other significant pain problem(s) that, in the opinion of the Investigator, might confound the study assessments.
•Subject is a woman of childbearing potential who is pregnant, nursing, or not using contraception.
•Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device.

Outcomes

Primary Outcomes

Primary Safety

Time Frame: One year post-implant

Characterization of all serious adverse events in all subjects who undergo an implantation procedure, through the completion of the Open Label Period.

Primary Efficacy

Time Frame: 28 weeks post-implant

Compared between the two study arms: Proportion of stimulation-treated ipsilateral cluster attacks that achieve pain relief at 15 minutes following the start of stimulation without the use of acute medications prior to that time point.