An interventional study of ThermoNeuroModulation (TNM) Device in Healthy Volunteer, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-21.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-invasive neurostimulator used for up to 20 minutes in a session.
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.
Time frame: 20 minutes
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.
Time frame: 40 minutes
Alterations in regional cerebral brain flow (rCBF)
A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment.
Time frame: 40 minutes
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Duke University