Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Completed · Not applicable

Conditions studied: Migraine Headache

In brief

This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve cells in the head, and is located near the base of the nose on either side. Participation involves the surgical implantation of an electrode (small electrical conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which will enable treatment for migraine headaches. Tiny electrical current is delivered to the stimulator device by an internal pulse generator implanted in the area at the top of the chest, to stop the migraine headaches. The implant system will be controlled with a wireless remote provided after the implant procedure. Participation will record headache diaries throughout the study, which will last approximately 8½ months, and a yearly visit annually for five years.

Key facts

Study ID

NCT01294046

Run by

The Cleveland Clinic

People needed

3

Starts

2011-03-01

Expected to finish

2014-03-01

Last updated by the study team

2017-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years.
• Subject has onset of migraine headache occurring before age 60.
• Subject has been diagnosed with migraine headache with or without aura, according to the 2004 IHS criteria 1.1 and 1.2.
• Subject reports a HIT-6 score of >56, a MIDAS score of >20 and/or a failure of adequate and appropriate previous migraine treatment.
• Subject has carried the diagnosis of migraine for at least 6 months prior to enrollment.
• Subject has had at least three migraine headache attacks per month.
• Subject has had at least three headache days (migraine or non-migraine) per month and maintains this requirement during the baseline period on diary.
• Subject is able to distinguish migraine headache attacks as discrete from other headaches (i.e., tension-type headaches).
• Subject has the ability to read, comprehend and legibly and reliably record information as required by the protocol.
• Subject is able to provide written informed consent prior to participation in the study.
• Subject agrees to not participate in supplemental or alternative therapy during the baseline or treatment phases of the clinical study. This includes: acupuncture, spinal manipulation, TENS, and magnetic field treatments.
• Subject agrees to maintain current preventative headache medication regimens (no change in type, frequency, or dose) from baseline screening visit to the end of the Phase 2 treatment phase.

You may not qualify if…

• Subject currently has Medication Overuse Headache (MOH) in the judgment of the investigator or by ICHD-II criteria.
• Subject has a history of headaches days ≥ 15 per month.
• Subject has a history of trigeminal autonomic cephalalgias.
• Subject has any medical condition or disorder that:
• Is considered to be clinically significant and may pose a safety concern
• Could interfere with the accurate assessment of safety or efficacy
• Could potentially affect a subject's safety or study outcome.
• Subject has had a major infection or surgery in the past month.
• Subject has undergone facial surgery in the area of sphenopalatine ganglia for cosmetic, corrective, therapeutic, or traumatic reasons.
• Subject has been treated with radiation to the face.
• Subject was diagnosed with any major infectious processes, primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
• 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 include: suicidality, active psychosis, untreated severe depression and/ or anxiety disorder, litigation, addiction, homicidal ideation, significant Axis II disorders and untreated sleep disorder.
• 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 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 is woman of childbearing age who is pregnant, nursing, or not using contraception.
• Subject has had previous radio-frequency ablation of the SPG.
• Subject has had blocks of the SPG in last 3 months.
• Subject has undergone botulinum toxin injections of the head and/or neck in the last 3 months.
• Subject has an implantable stimulator or any implanted devices in the head and/or neck.
• Subject has H/O bleeding disorders or coagulopathy, or is on anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication.
• Subject has H/O malignancy or any other condition that requires MRI monitoring.
• Subject has or requires pacemaker/defibrillator.
• Subject is not suitable for the study, in the judgment of the Investigators, due to social, co-morbid psychological, and/or medical considerations.
• Subject has H/O stroke, cardiovascular disease, and/or epilepsy.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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