Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02168764
Recruitment Status : Active, not recruiting
First Posted : June 20, 2014
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Cluster Headache Device: ATI Neurostimulation System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
Study Start Date : July 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Secondary Efficacy [ Time Frame: 28 weeks post-implant ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 3.1.2.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168764


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, Illinois
University of Chicago, Illinois - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER
Chicago, Illinois, United States, 60612
Diamond Headache Clinic
Chicago, Illinois, United States, 60642
Robbins Headache Clinic
Northbrook, Illinois, United States, 60062
United States, Kentucky
Norton Neurology Services
Louisville, Kentucky, United States, 40207-4723
United States, Massachusetts
New England Regional Headache Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, United States, 48104-5131
United States, Missouri
Mercy Health Research
Saint Louis, Missouri, United States, 63141
Headache Care Center (Springfield)
Springfield, Missouri, United States, 65807
United States, Nevada
Nevada Headache Institute
Las Vegas, Nevada, United States, 89113
United States, New Hampshire
Dartmouth Hitchcock-Medical Center
Lebanon, New Hampshire, United States, 03765
United States, New York
Dent Neurosciences Research Institute
Amherst, New York, United States, 14226
Lenox Hill Hospital, The New York Head and Neck Institute - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER
New York, New York, United States, 10022
Mount Sinai Hospital
New York, New York, United States, 10029
Island Neurological Association
Plainview, New York, United States, 11803
United States, North Carolina
Carolina Headache Institute
Durham, North Carolina, United States, 27713
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
United States, Pennsylvania
Jefferson Headache Center, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
University of Texas, Southwestern
Dallas, Texas, United States, 75390-9105
United States, Virginia
Inova Medical Group Neurology and Headache
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Peter J Goadsby, MD, PhD UCSF Medical Center, Headache Center
Principal Investigator: David W Dodick, MD Mayo Clinic, Department of Neurology

Layout table for additonal information
Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02168764     History of Changes
Other Study ID Numbers: Pathway CH-2
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Headache
Cluster Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases