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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Device: ThermoNeuroModulation (TNM) Device

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Scion NeuroStim
• Investigators: Principal Investigator: Daniel Laskowitz, MD, Duke University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Healthy volunteer
• Other Study ID Numbers: Pro00035775

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No