Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05145426

Enrollment

Registered

2021-12-06

Start date

2022-02-04

Completion date

2025-07-23

Last updated

2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Low-intensity focused ultrasound

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.

Interventions

DEVICELow Intensity Focused Ultrasound

Application of LIFU

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

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

Intervention model description

Multiple subject repeated measures

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026