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| Name | Class |
|---|---|
| Scion NeuroStim | INDUSTRY |
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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 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermoNeuroModulation (TNM) Device | Device | Non-invasive neurostimulator used for up to 20 minutes in a session. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cerebral blood flow | 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. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in EEG readings | EEG readings occurring between baseline, active CVS induction, and post-CVS induction periods will be assessed to identify and characterize alterations in the readings. | 40 minutes |
| Alterations in regional cerebral brain flow (rCBF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Laskowitz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D009367 | Neoplasm Staging |
| ID | Term |
|---|---|
| D011379 | Prognosis |
| D003933 | Diagnosis |
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A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment. |
| 40 minutes |