A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

Study Overview

• Status: Terminated
• Conditions: Intervention
• Intervention / Treatment: Device: active neuromodulation for episodic migraine headache; Device: placebo neuromodulation for episodic migraine headache

Detailed Description

This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Denmark Hill
    • London, Denmark Hill, United Kingdom, SE5 9PJ
      • King's College London
  • Kent
    • Canterbury, Kent, United Kingdom, CT2 7NP
      • University of Kent
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Neurology Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60642
      • Diamond Headache Clinic
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache Pain & Neurological Inst.
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • Study Metrix Research
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed with episodic migraine at least 6 months before study
• at least 3 consecutive months of stable migraine headaches before study
• at least 4-14 headache days per month, of which 4-14 may be migraines
• must not have failed on more than 2 classes of migraine preventatives

Exclusion Criteria:

• previous use of the experimental device
• pregnant
• using more than 1 concurrent migraine preventive
• history of cardiovascular disease
• work night shifts
• diagnosed with vestibular migraine
• menstrual migraines exclusively
• diagnosed with post-traumatic migraine
• have a history of unstable mood or anxiety disorder
• use a hearing aid
• have a cochlear implant
• have chronic tinnitus
• have temporomandibular joint disease
• diagnosed with traumatic brain injury
• diagnosed with neurological disease other than headaches
• diagnosed vestibular and/or balance dysfunction
• history of abusing alcohol or other drugs
• are experiencing medication overuse headaches
• have had eye surgery in the previous 3 months
• have had ear surgery in the previous 6 months
• have active ear infections or a perforated tympanic membrane
• have participated in another clinical trial in the last 30 days
• are currently participating in another clinical trial
• using Botulinum toxin-based treatments for migraines or cosmetic reasons
• taking anti-emetics more than 2 times per week (consistently)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active; active neuromodulation	Device: active neuromodulation for episodic migraine headache; Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Placebo Comparator: placebo; placebo neuromodulation	Device: placebo neuromodulation for episodic migraine headache; Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Migraine Headache Days (MHD)	comparison of MHD recorded in baseline month versus 3rd month of treatment	1 month of baseline recordation followed by 84 days of device use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalized Reduction in Migraine Headache Days	comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo	1 month of baseline recordation followed by 84 days of device use
Change in Medication Usage	reduction in acute, prescribed medications in month 3 of treatment versus baseline month	1 month of baseline recordation followed by 84 days of device use
Change in Headache Pain	reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month	1 month of baseline recordation followed by 84 days of device use
Change in Quality of Life	comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Change in Depression	comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Change in Anxiety	comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Change in Sleep Quality	comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Additional Treatment Time	comparison of MHD recorded in baseline month versus 6th month of treatment	1 month of baseline recordation followed by 168 days of device use
Sustained Reduction in Migraine Headache Days	comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9	1 month of baseline recordation followed by 252 days of device use

Collaborators and Investigators

• Sponsor: Scion NeuroStim

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): May 11, 2018
• Study Completion (Actual): May 11, 2018

Study Registration Dates

• First Submitted: December 4, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 15, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: migraine headache, episodic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: SNS-MIG-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes