Caloric Stimulation on Cerebral Blood Flow

The Effect of Vestibular Stimulation on Cerebral Blood Flow

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01629901

Enrollment

Registered

2012-06-28

Start date

2012-06-30

Completion date

2015-04-30

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy volunteer

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.

Interventions

DEVICEThermoNeuroModulation (TNM) Device

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in cerebral blood flow	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

Measure	Time frame	Description
Alterations in EEG readings	40 minutes	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)	40 minutes	A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026