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Clinical Trials/NCT01629901
NCT01629901
Completed
N/A

The Effect of Vestibular Stimulation on Cerebral Blood Flow

Duke University1 site in 1 country10 target enrollmentJune 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Volunteer
Sponsor
Duke University
Enrollment
10
Locations
1
Primary Endpoint
Changes in cerebral blood flow
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
April 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Changes in cerebral blood flow

Time Frame: 20 minutes

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 Outcomes

  • Alterations in EEG readings(40 minutes)
  • Alterations in regional cerebral brain flow (rCBF)(40 minutes)

Study Sites (1)

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