Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

Chronic Cluster Headache Clinical Trial

Official title:

Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02168764
• Other study ID #: Pathway CH-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: March 2020

Study information

• Verified date: June 2018
• Source: Autonomic Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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 3.1.2.

• 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.

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.

• Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or maintaining a stable headache medicine regimen or returning for required follow-up visits).

• Subject is at risk of being unable to complete at least 1 year of follow-up (e.g., has plans to relocate).

• Subject has had previous lesional radio-frequency (RF) ablation, balloon compression, gamma knife, or glycerol treatments of the ipsilateral sphenopalatine ganglion (SPG), trigeminal ganglion or any branch of the trigeminal nerve.

• Subject has had blocks or non-lesional pulsed RF of the ipsilateral SPG in the last three (3) months.

• Subject's pterygomaxillary fissure is less than 1.2 mm in width at the level of the vidian canal, as determined by CT scan.

• Subject has undergone onabotulinumtoxinA injections of the head and/or neck or has had an occipital nerve block in the last three (3) months.

• Subject has or requires an active implanted medical device, such as a pacemaker/defibrillator, other neurostimulator, or cochlear implant.

• Subject is expected to require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS).

• Subject has a history of bleeding disorders or coagulopathy and is unable to discontinue anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication in preparation for the implantation procedure.

• In the opinion of the Investigator, the subject currently meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for an active major depressive episode or for active significant psychiatric disorders, including dementia, uncontrolled general anxiety disorder, psychotic disorders or uncontrolled bipolar disorder. Exclusion criteria also include: active psychosis, untreated severe anxiety disorder, homicidal ideation, significant Axis II disorders and significant untreated sleep disorders.

• Subject currently has clinically significant drug or alcohol abuse as defined by DSM-IV-TR or is unable to refrain from substance abuse throughout the study.

• Subject has a history of malignancy or any other condition that requires MRI monitoring.

• Subject has a history of allergic or hypersensitive reactions to titanium, platinum, or implant grade silicone-polyurethane copolymers.

• Subject may be, in the opinion of the Investigator, at greater risk of infection (e.g., subjects with diabetes, taking steroids, with gingivitis/periodontitis, malnutrition or anorexia/bulimia) or at higher risk of harm from infections.

• Subject is currently using a tobacco cessation regimen (e.g. Wellbutrin, Zyban, Aplenzin, etc.).

• Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the Investigator.

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Headache

Intervention

Device:
• ATI Neurostimulation System
All subjects will be implanted with the ATI Neurostimulator which, along with the ATI Remote Controller, provides electrical stimulation.

Locations

Country	Name	City	State
United States	Dent Neurosciences Research Institute	Amherst	New York
United States	Michigan Headache and Neurological Institute	Ann Arbor	Michigan
United States	Diamond Headache Clinic	Chicago	Illinois
United States	University of Chicago, Illinois - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Texas, Southwestern	Dallas	Texas
United States	Carolina Headache Institute	Durham	North Carolina
United States	Inova Medical Group Neurology and Headache	Falls Church	Virginia
United States	Nevada Headache Institute	Las Vegas	Nevada
United States	Dartmouth Hitchcock-Medical Center	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	Norton Neurology Services	Louisville	Kentucky
United States	Yale University	New Haven	Connecticut
United States	Lenox Hill Hospital, The New York Head and Neck Institute - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Robbins Headache Clinic	Northbrook	Illinois
United States	Jefferson Headache Center, Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	Island Neurological Association	Plainview	New York
United States	Mercy Health Research	Saint Louis	Missouri
United States	Headache Care Center (Springfield)	Springfield	Missouri
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	Stanford University	Stanford	California
United States	New England Regional Headache Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Autonomic Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety	Characterization of all serious adverse events in all subjects who undergo an implantation procedure, through the completion of the Open Label Period.	One year post-implant
Primary	Primary Efficacy	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.	28 weeks post-implant
Secondary	Secondary Efficacy	Compared between the two study arms: Proportion of stimulation-treated ipsilateral cluster attacks that achieve pain freedom at 15 minutes following the start of stimulation without the use of acute medications prior to that time point.	28 weeks post-implant