Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- High Frequency, High Disability Migraine
- Sponsor
- Autonomic Technologies, Inc.
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Major Device- and Surgical-Related Complications
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years old.
- •Subject has been diagnosed at least 3 months prior to study enrollment with migraine headache with or without aura according to the 2004 ICHD-II criteria 1.1 or 1.2.1.
- •Subject reports at least 75% of migraine attacks having predominantly fixed (non side-shifting) unilateral temporal or ocular pain.
- •Subject reports that moderate/severe migraine pain is typically preceded by a mild pain phase.
- •Subject reports a minimum of 8 days per month and a maximum of 14 days per month with migraine attacks of at least moderate severity based on the subject/Investigator's knowledge for at least 3 months prior to inclusion and confirmed for at least 1 month during the Pre-Implant Baseline Period using the Pathway M-1 Daily Headache Diary.
- •Subject reports at least 24 hours of pain-free periods between typical migraine attacks.
- •Subject has a MIDAS grade of III or IV, or has a HIT-6 score \>
- •Subject is medically intractable in the opinion of the Investigator.
- •Subject has had stable type and dosage of preventive headache medications for at least 1 month prior to study enrollment and agrees to maintain stable type and dosage of preventive headache medications through the completion of the Experimental Period.
- •Subject is able to distinguish migraine attacks from other headaches (i.e., TTH).
Exclusion Criteria
- •Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anesthesia.
- •Subject has been diagnosed with chronic migraine during the last year according to 2006 ICHD-IIR Appendix 1.5.
- •Subject currently has Medication Overuse Headache (MOH) or has a history of MOH during the last year according to the ICHD-2R 2006 criteria.
- •Subject has used any triptans, pain medications or analgesics of any kind for any indication on more than 14 days per month over the last three months.
- •Subject reports continuous daily headaches for one month or longer at time of consent.
- •Subject reports initial onset of migraines within the last year.
- •Subject has undergone facial surgery or has metallic implants 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 the inability to properly implant or use the Neurostimulator.
- •Subject has active oral or dental abscess.
- •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 6 months or require periodic MRI follow-up.
Outcomes
Primary Outcomes
Major Device- and Surgical-Related Complications
Time Frame: Implantation through completion of Experimental Period (18 weeks following the implantation procedure)
Occurrence rate of death, any surgery or hospitalization due to deterioration in subject health, or other Major Device-related Adverse Events
Effective Therapy
Time Frame: During Experimental Period (12 to 18 weeks following implantation)
Number of Migraine Pain Days during the Experimental Period, compared between the Treatment and Control arms. Migraine Pain Day is any calendar day that: 1. Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND 2. No Acute Headache or Migraine Pain Medication (pharmacologic medications, not including SPG stimulation, used to treat acute headache pain). AND 3. No SPG stimulation is applied for headache pain of any intensity