Neurostimulation Device for Treatment of Migraine Headache

This study has been completed.
Scion NeuroStim
Information provided by (Responsible Party):
Duke University Identifier:
First received: June 5, 2012
Last updated: July 15, 2015
Last verified: June 2015
This is a prospective, non-randomized and unblinded study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator to treat migraine headaches in patients with episodic migraine headaches.

Condition Intervention
Migraine Headache
Device: ThermoNeuroModulation (TNM) Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of migraine headache days [ Time Frame: Length of the study, about 71 days ] [ Designated as safety issue: No ]
    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.

  • Severity of each and of all headaches [ Time Frame: Length of study, 71 days ] [ Designated as safety issue: No ]
    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:
  • Total Monthly Headache Pain Score [ Time Frame: Length of study, about 71 days ] [ Designated as safety issue: No ]
    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.

Enrollment: 7
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ThermoNeuroModulation (TNM) Device
    Non-invasive neurostimulator, home-use treatment for up to 43 days.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT01630044

United States, North Carolina
Duke Medicine / Neurology
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Scion NeuroStim
Principal Investigator: Daniel Laskowitz, MD Duke University
  More Information

Responsible Party: Duke University Identifier: NCT01630044     History of Changes
Other Study ID Numbers: Pro00037089 
Study First Received: June 5, 2012
Last Updated: July 15, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 26, 2016