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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||The Effect of Vestibular Stimulation on Cerebral Blood Flow|
- Changes in cerebral blood flow [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]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.
- Alterations in EEG readings [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]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) [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Device: ThermoNeuroModulation (TNM) Device
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629901
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Ellen Bennett, PhD 919-668-1429 firstname.lastname@example.org|
|Principal Investigator:||Daniel Laskowitz, MD||Duke University|