Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Low Intensity Focused Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand and speak English Exclusion Criteria: MRI/CT/EEG contraindications. Claustrophobia Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants. Contraindications to CT: pregnancy Active medical disorder or treatment with potential CNS effects History of neurologic disorder History of head injury resulting in loss of consciousness for >10 minutes. History of alcohol or drug dependence Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Multiple subject repeated measures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Trials<br>Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device). | Device: Low Intensity Focused Ultrasound<br>* Application of LIFU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | Assessed per participant, over the course of participation - an average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-intensity focused ultrasound