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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

June 26, 2012
April 8, 2013
June 2012
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01629901 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Caloric Stimulation on Cerebral Blood Flow
The Effect of Vestibular Stimulation on Cerebral Blood Flow

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.

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy Volunteer
Device: ThermoNeuroModulation (TNM) Device
Non-invasive neurostimulator used for up to 20 minutes in a session.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Not Provided
United States
 
NCT01629901
Pro00035775
No
Duke University
Duke University
SCION NeuroStim, LLC
Principal Investigator: Daniel Laskowitz, MD Duke University
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP