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Neurostimulation Device for Treatment of Migraine Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630044
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Scion NeuroStim

Brief Summary:
This is a prospective, non-randomized and unblinded study designed to generate preliminary data to assess the effect of a new portable non-invasive brainstem stimulator to treat migraine headaches in patients with episodic migraine headaches.

Condition or disease Intervention/treatment Phase
Migraine Headache Device: TNM device Not Applicable

Detailed Description:
This study is a single-center, unblinded, non-randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache
Study Start Date : May 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: TNM device, active treatment
This is an active-only assessment of the experimental neuromodulation device
Device: TNM device
Non-invasive neurostimulator, home-use treatment for up to 43 days.

Primary Outcome Measures :
  1. Number of migraine headache days [ Time Frame: Length of the study, about 71 days ]
    Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache.

  2. Severity of each and of all headaches [ Time Frame: Length of study, 71 days ]
    Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain).

Secondary Outcome Measures :
  1. Total Monthly Headache Pain Score [ Time Frame: Length of study, about 71 days ]
    The monthly measure would be the cumulative maximal headache pain scores for all headache days (days on which the subject's head pain level is one or higher on the pain measurement scale) during the month.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • On a Monthly basis, at least four, and not more than a total of fourteen Headache Days (Pain Score between one and ten) of which between four and nine are Migraine Headache Days (Pain Score between five and ten). NOTE: For clarification, the occurrence of Headaches is counted taking into account, and making no adjustments for, the medications that the subjects are taking;
  • A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
  • The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
  • Subject must be at least 18 years of age.

Exclusion Criteria:

  • Individuals who are pregnant, who have a history of cardiovascular disease, who work night shifts or who have vestibular migraine, menstrual migraine, posttraumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury will be excluded from the Study.
  • A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01630044

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United States, North Carolina
Duke Medicine / Neurology
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Scion NeuroStim
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Principal Investigator: Daniel Laskowitz, MD Duke University
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Responsible Party: Scion NeuroStim Identifier: NCT01630044    
Other Study ID Numbers: Pro00037089
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations