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Neurostimulation Device for Treatment of Migraine Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scion NeuroStim
ClinicalTrials.gov Identifier:
NCT01630044
First received: June 5, 2012
Last updated: December 20, 2016
Last verified: December 2016
  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 brainstem stimulator to treat migraine headaches in patients with episodic migraine headaches.

Condition Intervention
Migraine Headache
Device: TNM device

Study Type: Interventional
Study Design: 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 Scion NeuroStim:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.


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)
Arms Assigned Interventions
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.

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01630044

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

Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT01630044     History of Changes
Other Study ID Numbers: Pro00037089 
Study First Received: June 5, 2012
Last Updated: December 20, 2016
Individual Participant Data  
Plan to Share IPD: No

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 February 20, 2017