Clinical trial NCT05145426: Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Official title: Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Pain
Keywords: Low-intensity focused ultrasound
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple subject repeated measures
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Understand and speak English

Exclusion Criteria:

* MRI/CT/EEG contraindications.

  1. Claustrophobia
  2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Contraindications to CT: pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for \>10 minutes.
  7. History of alcohol or drug dependence
  8. Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.

Primary outcomes:
measure: Perceived sensation score
timeFrame: Assessed per participant, over the course of participation - an average of 3 weeks.
Secondary outcomes:
measure: Windup Pain
timeFrame: Assessed per participant, over the course of participation - an average of 3 weeks
measure: CHEP Amplitude
timeFrame: Assessed per participant, over the course of participation - an average of 3 weeks
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.