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This project examines the effects of noninvasive brain stimulation on pain. The investigators believe this study will help to better understand possible treatments for chronic pain patients. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) device which uses sound waves to temporarily change brain activity. Pain testing is done using a small device that will increase/decrease the temperature of the skin. Brain signals are collected using electroencephalography (EEG). Heart rate, blood pressure, and skin moisture will be monitored as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Trials | Experimental | Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Focused Ultrasound | Device | Application of LIFU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived sensation score | Changed perceived sensation score on a 1-10 scale in response to painful stimuli. | Assessed per participant, over the course of participation - an average of 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Windup Pain | Changed windup pain score on a 1-10 scale. | Assessed per participant, over the course of participation - an average of 3 weeks |
| CHEP Amplitude | Attenuated N1/P1 CHEP amplitude recorded with EEG |
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Inclusion Criteria:
Exclusion Criteria:
MRI/CT/EEG contraindications.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute | Roanoke | Virginia | 24016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24413698 | Background | Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12. | |
| 20103504 | Background | Tyler WJ. Noninvasive neuromodulation with ultrasound? A continuum mechanics hypothesis. Neuroscientist. 2011 Feb;17(1):25-36. doi: 10.1177/1073858409348066. Epub 2010 Jan 25. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Multiple subject repeated measures
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Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
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| Assessed per participant, over the course of participation - an average of 3 weeks |
| 29463641 | Background | Kubanek J, Shukla P, Das A, Baccus SA, Goodman MB. Ultrasound Elicits Behavioral Responses through Mechanical Effects on Neurons and Ion Channels in a Simple Nervous System. J Neurosci. 2018 Mar 21;38(12):3081-3091. doi: 10.1523/JNEUROSCI.1458-17.2018. Epub 2018 Feb 20. |
| 27782686 | Background | Kamimura HA, Wang S, Chen H, Wang Q, Aurup C, Acosta C, Carneiro AA, Konofagou EE. Focused ultrasound neuromodulation of cortical and subcortical brain structures using 1.9 MHz. Med Phys. 2016 Oct;43(10):5730. doi: 10.1118/1.4963208. |
| 38314779 | Derived | Legon W, Strohman A, In A, Payne B. Noninvasive neuromodulation of subregions of the human insula differentially affect pain processing and heart-rate variability: a within-subjects pseudo-randomized trial. Pain. 2024 Jul 1;165(7):1625-1641. doi: 10.1097/j.pain.0000000000003171. Epub 2024 Feb 1. |