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Completed

NCT Number: NCT01629901

Caloric 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ThermoNeuroModulation (TNM) Device

Device

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

Primary outcomes

  1. 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

  1. Alterations in EEG readings

    Time frame: 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.

  2. Alterations in regional cerebral brain flow (rCBF)

    Time frame: 40 minutes

    A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Scion NeuroStim

Registry information

Official study title

The Effect of Vestibular Stimulation on Cerebral Blood Flow

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 28, 2012
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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