A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

NCT01899040 | Completed Results

• 1 other identifier: SNS-MIG-01
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.

Conditions

Migraine Headache, Episodic

Keywords

neuromodulation; migraine headache; CVS

Outcome Measures

Primary Outcomes (1)

• Change in Number of Monthly Migraine Headache Days

  Change in the average total number of Monthly Migraine Headache Days (number of days in the month that a participant experienced a migraine) after 3 months of treatment comparable to the pre-device use Baseline Period of 1 month, as reported in a headache diary. Negative number indicated improvement (a reduction in the average number of migraine headache days experienced per month).

  after 84 days of Device use

Secondary Outcomes (7)

• Number of Monthly Migraine Headache Days (Reduction by by 50% or More)

  after 84 days of Device use

• Total Monthly Headache Pain Score

  after 84 days of Device use

• (Safety Measure) Mood and Cognition - Change in Beck Depression Index Score

  after 84 days of Device use

• (Safety Measure) Dizziness: Verify the Absence of Change in Material Dizziness (Berg Balance)

  after 84 days of Device use

• (Safety Measure) Mood and Cognition - Change in Digit Symbol Coding Cognitive Speed

  after 84 days of Device use

Study Arms (2)

active device

ACTIVE COMPARATOR

A standardized active neuromodulation waveform will be used for all active Device patients at all Study sites. The Device will be used twice daily.

Device: neuromodulation for episodic migraine headache

placebo device

PLACEBO COMPARATOR

A standardized placebo neuromodulation waveform will be used for all placebo Device patients at all Study sites. The Device will be used twice daily.

Device: neuromodulation for episodic migraine headache

Interventions

neuromodulation for episodic migraine headache DEVICE

active device; placebo device

Eligibility Criteria

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

You may qualify if:

• The patient must have been diagnosed with episodic Migraine Headache at least 6 months prior to entering into the Study, consistent with the International Headache Classification of Headache Disorders-II (ICHD-II) guidelines.
• The patient must have a history of at least three consecutive months of stable Migraine Headaches prior to entering the Study. The patients will not have had changes in medication usage for the three Months leading up to the Study, nor will they introduce new medications during the Study period. Patients will satisfy these criteria: On a Monthly basis, at least four, and not more than a total of fourteen (4-14), Headache Days (Pain Score between one and ten) of which between four and nine (4-14) are Migraine Headache Days
• The patient must not have failed on more than two classes of properly administered prophylactic pharmaceutical therapies for migraine headache. The patient may be on a single migraine prophylactic as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the duration of the study.
• The Investigator must have confidence in the patient's ability to reliably use the Experimental Device and promptly complete the Daily Headache Diary forms. The Daily Headache Diary will be completed from the beginning of the Pre-Treatment Baseline Period through the end of the Pivotal Study.

You may not qualify if:

• Individuals who:
• are pregnant
• have a history of cardiovascular disease
• work night shifts
• have been diagnosed with vestibular migraine
• have been diagnosed with migraine with aura
• have menstrual migraine exclusively
• have been diagnosed with post-traumatic migraine
• have a history of unstable mood disorder or unstable anxiety disorder
• use a hearing aid
• have a cochlear implant
• have chronic tinnitus
• have temporomandibular joint (TMJ) disease
• have been diagnosed with traumatic brain injury (TBI)
• have been diagnosed with neurological disease other than Headaches

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (6)

Naval Medical Center

San Diego, California, 92134, United States

Location

Michigan Headache and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Carolina Headache Institute

Chapel Hill, North Carolina, 27516, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Kent University

Canterbury, Kent, CT2 7NP, United Kingdom

Location

Related Publications (1)

• Wilkinson D, Ade KK, Rogers LL, Attix DK, Kuchibhatla M, Slade MD, Smith LL, Poynter KP, Laskowitz DT, Freeman MC, Hoffer ME, Saper JR, Scott DL, Sakel M, Calhoun AH, Black RD. Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. Headache. 2017 Jul;57(7):1065-1087. doi: 10.1111/head.13120. Epub 2017 Jun 27.

  PMID: 28656612 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Recurrence

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The devices of the first 20 placebo-randomized participants were found to be delivering a partially active treatment. Not yet distributed devices were corrected to ensure they were fully inactive and were supplied to all other placebo-randomized participants thereafter. 2 participants were found to have not met the criteria after inclusion into the study. These results weren't included in the primary/some secondary outcome analyses, as they artificially inflated the effectiveness of the device

Results Point of Contact

• Title: Robert Black
• Organization: Scion NeuroStim, Inc

bacllc@earthlink.net

919-260-5528

Study Officials

• Lesco Rogers, MD

  Scion NeuroStim

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was designed with two arms - active and placebo. The devices for the first 20 placebo-randomized participants were found to be partially active. Therefore, the fully placebo arm was separated into placebo and partially active placebo. Only the active and placebo arms were followed (and outcomes posted) for effectiveness. All (active, placebo, and partially active) were followed and outcomes posted for safety.

Study Record Dates

• First Submitted: June 29, 2013
• First Posted: July 15, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Locations

GB (1); US (5)