Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events via a neurological examination
Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire
Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Heart Rate (HR)
changes in HR compared pre/post LIFU and at follow up
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Respiration Rate (RR)
changes in RR compared pre/post LIFU and at follow up
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.
changes in mood scale compared pre/post LIFU and at follow up
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Blood Pressure (BP)
changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
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