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NCT01629901 Clinical Trial

Caloric Stimulation on Cerebral Blood Flow

Healthy Volunteer Clinical Trial

Official title:
The Effect of Vestibular Stimulation on Cerebral Blood Flow

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01629901
Other study ID # Pro00035775
Secondary ID
Status Completed
Phase N/A
First received June 26, 2012
Last updated March 20, 2017
Start date June 2012
Est. completion date April 2015

Study information
Verified date June 2015
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ThermoNeuroModulation (TNM) Device
Non-invasive neurostimulator used for up to 20 minutes in a session.

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Scion NeuroStim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in cerebral blood flow 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. 20 minutes
Secondary Alterations in EEG readings EEG readings occurring between baseline, active CVS induction, and post-CVS induction periods will be assessed to identify and characterize alterations in the readings. 40 minutes
Secondary Alterations in regional cerebral brain flow (rCBF) A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment. 40 minutes
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