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

NCT01294046 | Completed Results DMC

• 1 other identifier: IDE Number : G100007
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache

Keywords

Episodic migraine headache

Outcome Measures

Primary Outcomes (1)

• Migraine Relief at 2 Hours Post Stimulation

  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.

  8.5 Months

Secondary Outcomes (9)

• Migraine Free at 2 Hours

  8.5 Months

• Pain Free at 2 Hours Post Stimulation

  8.5 months

• Acute Migraine Medication Use

  8.5 months

• Headache Impact Test (HIT-6) Compared With Baseline

  8.5 months

• Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline

  8.5 months

Study Arms (1)

Deep brain stimulation of SPG for migraine

EXPERIMENTAL

Electrical SPG for Treatment of Migraine

Device: Deep Brain Stimulation of SPG for Migraine

Interventions

Deep Brain Stimulation of SPG for Migraine DEVICE

Deep Brain Stimulation of SPG for Migraine

Also known as: Medtronic 37702 PrimeAdvanced™

Deep brain stimulation of SPG for migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Autonomic Technologies, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Kathryn O'Connor
• Organization: Cleveland Clinic

oconnok@ccf.org

Study Officials

• Stewart J Tepper, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 11, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 14, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)