Neurostimulation Device for Treatment of Migraine Headache

This study has suspended participant recruitment.
(Under FDA review)
Sponsor:
Collaborator:
Scion NeuroStim
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01630044
First received: June 5, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630044

Locations
United States, North Carolina
Duke Pain and Headache Clinic
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Scion NeuroStim
Investigators
Principal Investigator: Heather Adkins, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01630044     History of Changes
Other Study ID Numbers: Pro00037089
Study First Received: June 5, 2012
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 20, 2014