A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache, Episodic
• Intervention / Treatment: Device: neuromodulation for episodic migraine headache

Detailed Description

This is a multi-center, triple-blinded, placebo-controlled, randomized pivotal trial evaluating the adjunctive prophylactic treatment of episodic migraine headache using a caloric vestibular stimulation (CVS) device developed by Scion NeuroStim, LLC (SNS). This study has been reviewed by the FDA and is categorized as posing NSR (nonsignificant risk).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom, CT2 7NP
      • Kent University
• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache and Neurological Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Carolina Headache Institute
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center

Participation Criteria

Eligibility Criteria

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

Description

INCLUSION CRITERIA:

• 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.

EXCLUSION CRITERIA:

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
• have a diagnosed vestibular dysfunction
• abuse alcohol or other drugs
• are experiencing medication overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
• are younger than 18 years or older than 65 years
• have had eye surgery within the previous three months or ear surgery within the previous six months
• have active ear infections or a perforated tympanic membrane
• have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
• are using Botox treatments for migraines
• Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to using the Device. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to stimulation. Such medications should also be avoided within four hours prior to a treatment.

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 device; 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 Comparator: placebo device; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Monthly Migraine Headache Days (Reduction by by 50% or More)	Number of participants that experienced a reduction of 50% or more in Monthly Migraine Headache Days (total days during a month on which a migraine occurred) during the third month of device use as compared with their pre-device use Baseline Period.	after 84 days of Device use
Total Monthly Headache Pain Score	After three months of Device use, the average Total Monthly Headache Pain Score compared to the average derived from the Pre-use Baseline Period (1 month). This is calculated by adding the cumulative maximum pain scores for all days the subject had a headache, as noted as the maximum daily headache pain score on a scale of 1 (lowest pain)-10 (highest pain) for each headache day as reported by the subject in their daily headache diary. Each month was counted as 28 days. Therefore, the total possible score for each month was 28-280. A negative number indicates a reduction in pain score.	after 84 days of Device use
(Safety Measure) Mood and Cognition - Change in Beck Depression Index Score	A patient's Pre-device use Baseline Period mood score from the Beck Depression Index is compared with those at the end of the 3 month Device use period. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, with each of the 21 items, rated on a 4-point scale (0-3). The total scores rage from 0-63. The higher the score the more depressed. Mood scores are assessed for: decline, no change, or an improvement. A negative score indicates improvement in mood.	after 84 days of Device use
(Safety Measure) Dizziness: Verify the Absence of Change in Material Dizziness (Berg Balance)	The purpose of this study endpoint is to verify, using the Berg Balance test, the absence of change in material dizziness (with the associated risk of falls) as a consequence of using the Device. The test consists of 14 balance- related tasks ranging from standing up from a sitting position to standing on one foot. Each task is graded from 0 - 4, and the final measure is the sum from all elements of the Test: • 41-56 = low risk of fall • 21-40 = medium risk of fall • 0-20 = high risk of fall. Possible scores range from 0-56. Scores of zero indicate no change in balance.	after 84 days of Device use
(Safety Measure) Mood and Cognition - Change in Digit Symbol Coding Cognitive Speed	A patient's Pre-use Baseline Period cognitive speed scores, using the Digit Symbol Coding assessment, will be compared with those at the end of the Device use period. The Digit-Symbol Subtest of the WAIS-III, is a timed pencil-and-paper task that measures processing speed and visual-motor coordination. It involves matching symbols to numbers using a key, with the goal of completing as many correct matches as possible within a 120-second time limit. The number of correct matches completed is counted. The lowest possible count is 0 (zero correct matches). The higher the number of correct matches completed, the better the cognitive speed of the participant. Cognitive speed will be assessed for: a decline, no change, or an improvement. A positive number indicates improvement.	after 84 days of Device use
(Safety Measure) Mood and Cognition Measure - Change in Short Term Memory Test Scores	A patient's Pre-use Baseline Period memory scores, using Short Term memory test (an old/new paradigm for face recognition) are compared with those at the end of the 3-month Device use period. This assessment was created by the study Neuropsychologist where participants were shown faces at baseline then shown another set which included a subset then had seen before and had to say if they had seen them before later during the visit (to test short term memory). Scores range from 0-10. Higher scores indicate better short term memory. Memory scores were assessed for: a decline, no change, or an improvement from baseline to the end of treatment month 3. A negative score indicates improvement.	after 84 days of Device use
Average of Monthly Treated Headaches (Acute Anti-migraine Prescription Drug Intake)	This measures counts the number of times abortive medications are taken. The baseline count is subtracted from the third month count. A negative number indicates a reduction in abortive medications used. The greater the negative number, the more reduced the use of abortive medications.	after 84 days of device use

Collaborators and Investigators

• Sponsor: Scion NeuroStim
• Investigators: Study Director: Lesco Rogers, MD, Scion NeuroStim

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 29, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimated): July 15, 2013

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: neuromodulation; CVS; migraine headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: SNS-MIG-01