Caloric Stimulation on Cerebral Blood Flow

Duke University

Status: Completed

Conditions: Healthy Volunteer

Treatments: Device: ThermoNeuroModulation (TNM) Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01629901

Pro00035775

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)