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A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.
A single-arm, open label, 2 cohort (chronic pain/GAD) case study with extended (6 months) follow-up following accelerated low-intensity focused ultrasound for neuromodulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-intensity focused ultrasound for neuromodulation | Experimental | Accelerated (repeat) LIFU application for neuromodulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Focused Ultrasound | Device | Low-Intensity Focused Ultrasound applied multiple times in a single study visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - monitoring of possible symptoms | Symptom monitoring before and after LIFU applications and throughout 6 months of follow-up. Each symptom is presented with a likert scale (absent, mild, moderate, severe) - along with a free response option for any symptoms not included in the list. | Throughout study participation at multiple time points, approximately 6 months. |
| Changes in Chronic Pain - self report | Participants will complete the Brief Pain Inventory (BPI) at multiple time points throughout the 6 month period. This questionnaire asks participants to rate their pain on a 10 point scale (10 being the most pain). | Multiple timepoints throughout the 6 month experimental timeframe. |
| Changes in Anxiety - self report | Participants will complete the Beck Anxiety Inventory (BAI) at multiple time points before and after LIFU application to track changes in anxiety throughout the 6 month timeframe. The BAI probes different symptoms of anxiety and participants rate it on a likert scale (not at all, mildly, moderately, or severely). | Throughout the experimental timeframe, approximately 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Research Associate, 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 | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |