Investigation of Low-intensity Focused Ultrasound Pressure

Conditions

• Somatic Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• low-intensity focused ultrasound - low pressure — DEVICE
  low-intensity focused ultrasound applied to the S1.
• low-intensity focused ultrasound - medium pressure — DEVICE
  low-intensity focused ultrasound applied to the S1.
• low-intensity focused ultrasound - high pressure — DEVICE
  low-intensity focused ultrasound applied to the S1.

Study Details

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

Key Dates

Start date

Oct 16, 2024

Status verified

Dec 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Safety Check - high pressure application
  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.
• Experimental: EEG
  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).
• Experimental: fMRI
  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).

Primary Outcome Measure

Report of Symptoms Questionnaire [ Time Frame: pre/post intervention and 1 week post intervention. ]

Locations (1)

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