Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Virginia Polytechnic Institute and State University61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Perceived sensation score

Changed perceived sensation score on a 1-10 scale in response to painful stimuli.

Time frame: Assessed per participant, over the course of participation - an average of 3 weeks.

Secondary Outcomes

Windup Pain

Changed windup pain score on a 1-10 scale.

Time frame: Assessed per participant, over the course of participation - an average of 3 weeks

CHEP Amplitude

Attenuated N1/P1 CHEP amplitude recorded with EEG