A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Scion NeuroStim
Sponsor:
Information provided by (Responsible Party):
Scion NeuroStim
ClinicalTrials.gov Identifier:
NCT01899040
First received: June 29, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Migraine Headache, Episodic
Device: neuromodulation for episodic migraine headache

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

Resource links provided by NLM:


Further study details as provided by Scion NeuroStim:

Primary Outcome Measures:
  • Number of monthly migraine headache days [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of monthly migraine headache days (reduction by by 50% or more) [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: No ]
    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.

  • Total monthly pain score [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: No ]
    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.

  • Mood and cognition measures - Change in mood scores [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: No ]
    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.

  • Verify the absence of material dizziness [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: Yes ]
    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.

  • Mood and cognition measures - Change in cognitive speed scores [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: No ]
    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.

  • Mood and cognition measures - Change in memory scores [ Time Frame: after 84 days of Device use ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 76
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899040

Contacts
Contact: Kathryn Poynter, RN, CCRP 336-907-5092 poynterkathryn@yahoo.com
Contact: Robert Black, Ph.D. 919-260-5528 bacllc@earthlink.net

Locations
United States, California
Naval Medical Center Recruiting
San Diego, California, United States, 92134
Contact: Karen Bartku, CCRC    619-532-6965    karen.bartku.ctr@med.navy.mil   
Contact: Michael Hoffer, MD    619-532-6964    michael.hoffer@med.navy.mil   
Principal Investigator: Michael Hoffer, MD         
United States, Michigan
Michigan Headache and Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Shawn Szalay, R.N.    734-677-6000    sszalay@mhni.com   
Contact: Anita Severance, R.N.    734-677-6000 ext 104    aseverance@mhni.com   
Principal Investigator: Joel Saper, MD         
United States, North Carolina
Carolina Headache Institute Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Amy Pruitt, MS    919-942-4424    pruitta@carolinaheadacheinstitute.com   
Principal Investigator: Anne Calhoun, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Karen Grace, RN, BSN    919-668-2844    karen.grace@duke.edu   
Contact: Daniel Laskowitz, MD, Ph.D.    919-684-0056    danl@neuro.duke.edu   
Principal Investigator: Daniel Laskowitz, MD         
Sub-Investigator: Dianne Scott, MD         
Headache Wellness Center Recruiting
Greensboro, North Carolina, United States, 27405
Contact: Stacey Gibson, BS, CCRC    336-574-8000    sgibson@headachewellnesscenter.com   
Contact: Shavonna Haamid, RMA    336-574-8000    shaamid@headachewellnesscenter.com   
Principal Investigator: Marshall Freeman, MD         
Sub-Investigator: Marina Kyazimova, PA-C         
United Kingdom
Kent University Recruiting
Kent, Canterbury, United Kingdom, CT2 7NP
Contact: Maria Gallagher, BS    011-44-1227-824772    mg335@kent.ac.uk   
Contact: David Wilkinson, Ph.D.    011-44-1227-824772    d.t.wilkinson@kent.ac.uk   
Principal Investigator: David Wilkinson, Ph.D.         
Sub-Investigator: Mohamed Sakel, MD         
Sponsors and Collaborators
Scion NeuroStim
Investigators
Study Director: Lesco Rogers, MD Scion NeuroStim
  More Information

No publications provided

Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT01899040     History of Changes
Other Study ID Numbers: SNS-MIG-01
Study First Received: June 29, 2013
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Scion NeuroStim:
neuromodulation
migraine headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014