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Chronic Cluster HeadacheNCT02168764

Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

A study testing ATI Neurostimulation System in people with Chronic Cluster Headache, run by Autonomic Technologies, Inc. at 24 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Chronic Cluster Headache
What is being tested?
ATI Neurostimulation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
24 sitesUnited States
Study dates
Jul 2014to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Dent Neurosciences Research Institute

    Amherst, New York, 14226

  • Michigan Headache and Neurological Institute

    Ann Arbor, Michigan, 48104-5131

  • University of Chicago, Illinois - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER

    Chicago, Illinois, 60612

  • Diamond Headache Clinic

    Chicago, Illinois, 60642

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212

  • University of Texas, Southwestern

    Dallas, Texas, 75390-9105

  • Carolina Headache Institute

    Durham, North Carolina, 27713

  • Inova Medical Group Neurology and Headache

    Falls Church, Virginia, 22042

  • Nevada Headache Institute

    Las Vegas, Nevada, 89113

  • Dartmouth Hitchcock-Medical Center

    Lebanon, New Hampshire, 03765

  • University of Southern California

    Los Angeles, California, 90033

  • Norton Neurology Services

    Louisville, Kentucky, 40207-4723

  • Yale University

    New Haven, Connecticut, 06519

  • Lenox Hill Hospital, The New York Head and Neck Institute - SURGICAL CENTER ONLY, NOT AN ENROLLING CENTER

    New York, New York, 10022

  • Mount Sinai Hospital

    New York, New York, 10029

  • Robbins Headache Clinic

    Northbrook, Illinois, 60062

  • Jefferson Headache Center, Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Island Neurological Association

    Plainview, New York, 11803

  • Headache Care Center (Springfield)

    Springfield, Missouri, 65807

  • Mercy Health Research

    St Louis, Missouri, 63141

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Stanford University

    Stanford, California, 94305

  • New England Regional Headache Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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.

Being tested
ATI Neurostimulation System
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATI Neurostimulation SystemDevice

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

Study groups in NCT02168764
Study groupRoleWhat they receive
TreatmentExperimentalBoth 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.
Receives: Device: ATI Neurostimulation System
ControlActive 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.
Receives: Device: ATI Neurostimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety

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

    Measured: One year post-implant

  2. 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.

    Measured: 28 weeks post-implant

Secondary outcomes (1)

  1. 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.

    Measured: 28 weeks post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02168764
Sponsor's protocol ID
Pathway CH-2
Status last verified
Jun 2018
First submitted
18 Jun 2014
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31701891

Questions about this trial

What is this clinical trial studying?

A study testing ATI Neurostimulation System in people with Chronic Cluster Headache, run by Autonomic Technologies, Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety (time frame: One year post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02168764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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