Investigation of Low-intensity Focused Ultrasound Pressure

Virginia Polytechnic Institute and State University

Status: Invitation-only

Conditions: Somatic Pain

Treatments: Device: low-intensity focused ultrasound - low pressure; Device: low-intensity focused ultrasound - high pressure; Device: low-intensity focused ultrasound - medium pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06343883

24-353

Details and patient eligibility

About

Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.

Full description

Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Understand and speak English

Exclusion criteria

1. Claustrophobia (scanning environment may be uncomfortable).
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 (e.g. Alzheimer's)
5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
6. History of head injury resulting in loss of consciousness for >10 minutes.
7. History of alcohol or drug dependence (through self-report).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Safety Check - high pressure application

Experimental group

Description:

Small cohort to be collected prior to other study cohorts. Highest of 3 pressures of interest will be applied to the S1 (somatosensory cortex) with a follow-up MRI conducted 24-72 hours post.

Treatment:

Device: low-intensity focused ultrasound - high pressure

EEG

Experimental group

Description:

Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure).

Treatment:

Device: low-intensity focused ultrasound - medium pressure

Device: low-intensity focused ultrasound - high pressure

Device: low-intensity focused ultrasound - low pressure

fMRI

Experimental group

Description:

Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure).

Treatment:

Device: low-intensity focused ultrasound - medium pressure

Device: low-intensity focused ultrasound - high pressure

Device: low-intensity focused ultrasound - low pressure