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| Name | Class |
|---|---|
| Salem VA Medical Center | UNKNOWN |
| Washington DC VA Medical Center | UNKNOWN |
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Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain, Craving, and Anxiety measures | Experimental | Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Intensity Focused Ultrasound | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | 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. | 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 | 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 | 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 | 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 | Assessed per participant, over the course of participation - an average of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Florig, MPH | Contact | 540-526-2261 | jnw@vtc.vt.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Recruiting | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
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| Low-Intensity Focused Ultrasound - sham | Device | A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain. |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |