Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Pain Trials Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device). |
Device: Low Intensity Focused Ultrasound
Application of LIFU
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Outcome Measures
Primary Outcome Measures
- Perceived sensation score [Assessed per participant, over the course of participation - an average of 3 weeks.]
Changed perceived sensation score on a 1-10 scale in response to painful stimuli.
Secondary Outcome Measures
- Windup Pain [Assessed per participant, over the course of participation - an average of 3 weeks]
Changed windup pain score on a 1-10 scale.
- CHEP Amplitude [Assessed per participant, over the course of participation - an average of 3 weeks]
Attenuated N1/P1 CHEP amplitude recorded with EEG
Eligibility Criteria
Criteria
Inclusion Criteria:
- Understand and speak English
Exclusion Criteria:
- MRI/CT/EEG contraindications.
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Claustrophobia
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Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
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Contraindications to CT: pregnancy
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Active medical disorder or treatment with potential CNS effects
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History of neurologic disorder
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History of head injury resulting in loss of consciousness for >10 minutes.
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History of alcohol or drug dependence
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Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Fralin Biomedical Research Institute | Roanoke | Virginia | United States | 24016 |
Sponsors and Collaborators
- Virginia Polytechnic Institute and State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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. Review.
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