Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01255813
First received: December 3, 2010
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.


Condition Intervention
Chronic Cluster Headache
Device: Stimulation (Sub-perception)
Device: Stimulation (Full)
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Resource links provided by NLM:


Further study details as provided by Autonomic Technologies, Inc.:

Primary Outcome Measures:
  • Number of device related Serious Adverse Events (SAEs) [ Time Frame: Implant through the Experimental Period ] [ Designated as safety issue: Yes ]
  • Acute Pain Relief response (as defined by patient) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Freedom [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Rescue medication use [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    Use of medications to treat headache pain within 90 minutes after initiating therapy.

  • Pain Relief after initiating therapy [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Pain Relief after initiating therapy [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Pain Relief after initiating therapy [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: December 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Control
No stimulation applied
Experimental: Sub-perception Device: Stimulation (Sub-perception)
Stimulation applied below the perception threshold
Experimental: Full Stimulation Device: Stimulation (Full)
Stimulation applied above the perception threshold

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 to 65 years old (inclusive).
  • Subject has been diagnosed with chronic cluster headache according to the 2004 International Headache Society (IHS) criteria 3.1.2.
  • Subject reports a minimum of 4 cluster headaches per week.
  • Subject reports dissatisfaction with current cluster headache treatment (Criterion includes both preventive or abortive therapy per the Investigator's standard of care. Reasons for dissatisfaction with existing headache therapies may include failure of therapies, contraindication, side effects of therapies, or patient refusal of available therapies)
  • Subject is able to distinguish cluster headaches from other headaches (i.e., tension-type headaches).
  • 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 has had a change in type or dosage of prophylactic headache medications < one (1) month prior to study enrollment
  • Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four (4) months.
  • Subject has active oral or dental abscess.
  • Subject has been treated with radiation to the facial region within the last six (6) months.
  • 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 that might confound the study assessments in the opinion of the Investigator.
  • Subject is a woman of childbearing age 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 is felt to be at risk of non-compliance (e.g., for completing the diary or maintaining a stable headache medicine regimen) in the Investigator's opinion.
  • Subject has had previous lesional radio-frequency ablation of the ipsilateral sphenopalatine ganglion (SPG).
  • Subject has had blocks of the ipsilateral SPG in the last three (3) months.
  • Subject has undergone botulinum toxin injections of the head and/or neck in the last three (3) months.
  • Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier.
  • Subject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication in preparation for the implantation procedure.
  • Subject is not suitable for the study for any reason in the judgment of the Investigator.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255813

Locations
Belgium
Citadelle Hospital
Liege, Belgium
Denmark
Danish Headache Center, Dept. of Neurology, Glostrup Hospital
Glostrup, Denmark, 2600
Germany
Headache Center, Dept. of Neurology, University Duisburg-Essen
Essen, Germany, 45147
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246
Spain
Department of Neurology, University Clinic Hospital, University of Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
Principal Investigator: Jean Schoenen, M.D. Professor of Functional Neuroanatomy, Leige University
  More Information

No publications provided

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01255813     History of Changes
Other Study ID Numbers: Pathway CH-1 (CIP-001)
Study First Received: December 3, 2010
Last Updated: October 9, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Autonomic Technologies, Inc.:
Chronic Cluster Headache

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

ClinicalTrials.gov processed this record on October 19, 2014