Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine Headache
- Sponsor
- The Cleveland Clinic
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Migraine Relief at 2 Hours Post Stimulation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
This application proposes a clinical study of electrical stimulation of the sphenopalatine ganglia (SPG) as a treatment for up to three individuals with episodic migraine headache. The present study is aimed at obtaining pilot data to guide a future controlled trial of this treatment modality. The study population will include individuals suffering from episodic migraine headaches with chronic severe disability, as demonstrated by the Migraine Disability Assessment Questionnaire (Lipton, 2000) and Headache Impact Test short form (HIT-6™) (Kosinski, 2003). The treatment involves implantation of an electrode into the SPG. The electrode is connected subcutaneously to an infraclavicular stimulator (PrimeAdvanced™ 37702 Multi-program Neurostimulator System, Medtronic Inc., Minneapolis MN). Proper electrode placement will be verified using anatomic and physiologic techniques. Participants will receive the Medtronic Model 3389 or 3387 lead, or Medtronic subcompact lead Model 3776-45, 3776-60, or 3776-75. Stimulation will be delivered in a range of frequencies from 20 to 130 Hz, and pulse width from 60 to 450 μsec, and a titrated voltage. The voltages used for chronic stimulation may range up to the pulse generator maximum of 10.5 volts but are anticipated to generally be below 3 volts, keeping below the 30 µcoulomb/cm² charge density safety limit, and below the threshold for adverse stimulation-related effects. The minimum number of contacts on the quadripolar leads will be activated as necessary to produce a response. The Prime Advanced neurostimulator to be used in this study allows the clinician to set all stimulation parameters including the maximum allowable amplitude. It is our responsibility to assure that appropriate stimulation parameters are used to result in appropriate electrical exposure charge density) below a 30 µC/cm2/phase limit. As is done with commercially available neurostimulators, during this study, we will utilize the charts presented in Figures 1 and 2 below to assist in selection of programming parameters, and this programming will be maintained by software controls within the neurostimulator. For this exploratory study of 3 patients, the maximum electrical stimulating parameters, resulting electrical exposure (e.g., charge density), will be determined using the methods described above. It is our responsibility to assure that safe stimulation parameters are used at all times and that the maximum settings do not exceed the safety limits. Our plan is to begin with lead 3776 if possible, because it does not require an extra extension, but we would use 3387 or 3389 if clinically indicated. The proposed study is a physician-sponsored research investigation of three patients, and the attention to stimulation parameters will be much greater than can be expected for a commercially released product. It is our responsibility within this investigational study to insure the selected stimulation parameters do not exceed the safety limit of 30μC/cm2/phase. Patients participating in the study will only be able to lower stimulation amplitudes, thereby keeping stimulation parameters BELOW any clinician set maximum. The only programs available to or accessible by the patients will maintain the previously described parameter set limitations. Thus, the programming of the Implantable Programmable Generator (IPG) will keep the three patients from stimulating outside or above the set and safe parameters. The primary outcome measures for assessing the efficacy of migraine treatment will be a subject reported daily diary noting frequency and intensity of headaches. During this investigation we will obtain preliminary controlled data on the safety and efficacy of SPG stimulation for migraine treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years.
- •Subject has onset of migraine headache occurring before age
- •Subject has been diagnosed with migraine headache with or without aura, according to the 2004 IHS criteria 1.1 and 1.
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Migraine Relief at 2 Hours Post Stimulation
Time Frame: 8.5 Months
Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
Secondary Outcomes
- Acute Migraine Medication Use(8.5 months)
- Headache Impact Test (HIT-6) Compared With Baseline(8.5 months)
- Migraine Free at 2 Hours(8.5 Months)
- Pain Free at 2 Hours Post Stimulation(8.5 months)
- Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline(8.5 months)
- Stimulation Related Adverse Events(8.5 months)
- Average Per Subject Reduction in Migraine Days/Month(8.5 months)
- Implantation and Stimulation Related Adverse Events(8.5 months)
- Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia(8.5 months)