Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2027-12-31

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.

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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multiple subject repeated measures

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.

Study Groups

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Pain Trials

Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).

Group Type EXPERIMENTAL

Low Intensity Focused Ultrasound

Intervention Type DEVICE

Application of LIFU

Interventions

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Low Intensity Focused Ultrasound

Application of LIFU

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes