Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
1 other identifier
interventional
120
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJune 26, 2018
June 1, 2018
4.7 years
June 18, 2014
June 25, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 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 Outcomes (1)
Secondary Efficacy
28 weeks post-implant
Study Arms (2)
Treatment
EXPERIMENTALBoth 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.
Control
ACTIVE COMPARATORBoth 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.
Interventions
All subjects will be implanted with the ATI Neurostimulator which, along with the ATI Remote Controller, provides electrical stimulation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of Southern California
Los Angeles, California, 90033, United States
Stanford University
Stanford, California, 94305, United States
Yale University
New Haven, Connecticut, 06519, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
University of Chicago, Illinois - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER
Chicago, Illinois, 60612, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
Robbins Headache Clinic
Northbrook, Illinois, 60062, United States
Norton Neurology Services
Louisville, Kentucky, 40207-4723, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104-5131, United States
Headache Care Center (Springfield)
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Nevada Headache Institute
Las Vegas, Nevada, 89113, United States
Dartmouth Hitchcock-Medical Center
Lebanon, New Hampshire, 03765, United States
Dent Neurosciences Research Institute
Amherst, New York, 14226, United States
Lenox Hill Hospital, The New York Head and Neck Institute - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER
New York, New York, 10022, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Island Neurological Association
Plainview, New York, 11803, United States
Carolina Headache Institute
Durham, North Carolina, 27713, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43212, United States
Jefferson Headache Center, Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Texas, Southwestern
Dallas, Texas, 75390-9105, United States
Inova Medical Group Neurology and Headache
Falls Church, Virginia, 22042, United States
Related Publications (1)
Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9.
PMID: 31701891DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Goadsby, MD, PhD
UCSF Medical Center, Headache Center
- PRINCIPAL INVESTIGATOR
David W Dodick, MD
Mayo Clinic, Department of Neurology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 20, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2019
Study Completion
March 1, 2020
Last Updated
June 26, 2018
Record last verified: 2018-06