Caloric Stimulation on Cerebral Blood Flow
- Conditions
- Healthy Volunteer
- Registration Number
- NCT01629901
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- no history of neurological disease
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States