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Caloric Stimulation on Cerebral Blood Flow

This study is currently recruiting participants.
Verified March 2013 by Duke University
Sponsor:
Collaborator:
SCION NeuroStim, LLC
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01629901
First received: June 26, 2012
Last updated: April 8, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.


Condition Intervention
Healthy Volunteer
 Device: ThermoNeuroModulation (TNM) Device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Vestibular Stimulation on Cerebral Blood Flow

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Changes in cerebral blood flow [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Changes in cerebral blood flow will be quantified through the use of bilateral transcranial Doppler (TCD). The baseline TCD of three vessels will be compared with measurements taken at 30 second intervals for 5 minutes after caloric stimulation.


Secondary Outcome Measures:
  • Alterations in EEG readings [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    EEG readings occurring between baseline, active CVS induction, and post-CVS induction periods will be assessed to identify and characterize alterations in the readings.

  • Alterations in regional cerebral brain flow (rCBF) [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ThermoNeuroModulation (TNM) Device
    Non-invasive neurostimulator used for up to 20 minutes in a session.
Detailed Description:

Study activities include monitoring with bilateral transcranial Doppler (TCD), EEG and continuous EKG monitoring at 30 second intervals for 5 minutes. This is followed by placement of the caloric stimulator investigational device for 20 minutes. An additional 20 minutes of TCD and EEG monitoring will also be recorded. This will end study participation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no history of neurological disease

Exclusion Criteria:

  • persons under the age of 18
  • pregnant or nursing women
  • history of neurological disease
  • history of psychiatric disease
  • congenital heart defect, known cardiac shunt
  • inner ear or pulmonary disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629901

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ellen Bennett, PhD     919-668-1429     benne020@mc.duke.edu    
Sponsors and Collaborators
Duke University
SCION NeuroStim, LLC
Investigators
Principal Investigator: Daniel Laskowitz, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01629901     History of Changes
Other Study ID Numbers: Pro00035775
Study First Received: June 26, 2012
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Healthy volunteer

ClinicalTrials.gov processed this record on May 19, 2013