Caloric Stimulation on Cerebral Blood Flow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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ThermoNeuroModulation (TNM) Device

Non-invasive neurostimulator used for up to 20 minutes in a session.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes