A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

May 4, 2018 updated by: Scion NeuroStim
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

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Canterbury
      • Kent, Canterbury, United Kingdom, CT2 7NP
        • Kent University
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 disease
  • have been diagnosed with traumatic brain injury
  • 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 less than 18 years old or greater than 65 years old
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of monthly migraine headache days
Time Frame: after 84 days of Device use
During the third Month of Device use, the average total number of Monthly Migraine Headache Days will be lower than comparable averages derived from the Pre-use Baseline Period
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)
Time Frame: after 84 days of Device use
A reduction of 50% or more in monthly Migraine Headache Days during the third Month of Device use as compared with the Pre-use Baseline Period.
after 84 days of Device use
Total monthly pain score
Time Frame: after 84 days of Device use
During the third Month of Device use, the average Total Monthly Headache Pain Scores will be lower than comparable averages derived from the Pre-use Baseline Period.
after 84 days of Device use
Mood and cognition measures - Change in mood scores
Time Frame: after 84 days of Device use
A patient's Pre-use Baseline Period mood scores will be compared with those at the end of the Device use period. Mood scores will be assessed for: a decline, no change, or an improvement.
after 84 days of Device use
Verify the absence of material dizziness
Time Frame: after 84 days of Device use
The principal safety endpoint for the Study is to verify the absence of material dizziness, with the associated risk of falls, as a consequence of using the Device.
after 84 days of Device use
Mood and cognition measures - Change in cognitive speed scores
Time Frame: after 84 days of Device use
A patient's Pre-use Baseline Period cognitive speed scores will be compared with those at the end of the Device use period. Cognitive speed scores will be assessed for: a decline, no change, or an improvement.
after 84 days of Device use
Mood and cognition measures - Change in memory scores
Time Frame: after 84 days of Device use
A patient's Pre-use Baseline Period memory scores will be compared with those at the end of the Device use period. Memory scores will be assessed for: a decline, no change, or an improvement.
after 84 days of Device use
Use of acute medications - change in number of treated headaches
Time Frame: after 84 days of device use
During the third month of device use, the number of abortive medications taken will be less than the number taken in the baseline month
after 84 days of device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Lesco Rogers, MD, Scion NeuroStim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

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 (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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