Investigation of Low-intensity Focused Ultrasound Pressure

N/AEnrolling By InvitationNCT06343883

Virginia Polytechnic Institute and State University25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Somatic Pain

Interventions

low-intensity focused ultrasound - low pressureDEVICE

low-intensity focused ultrasound applied to the S1.

low-intensity focused ultrasound - medium pressureDEVICE

low-intensity focused ultrasound applied to the S1.

low-intensity focused ultrasound - high pressureDEVICE

low-intensity focused ultrasound applied to the S1.

Eligibility

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

Medical Language ↔ Plain English

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).

Locations (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

Report of Symptoms Questionnaire

questionnaire of symptomology administered pre and post intervention.

Time frame: pre/post intervention and 1 week post intervention.

MRI

pre and post structural MRI collection for cohort one - evaluated by Neuroradiologist for safety considerations. Primarily looking to rule out any evidence of bleeds.

Time frame: pre and post intervention in cohort 1

Secondary Outcomes

EEG

Cohort 2 outcome measure is the EEG evoked potential response to the SEP stimulus pre and post LIFU application.

Time frame: throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).

fMRI

Cohort 3 outcome measure is the functional MRI response to the SEP stimulus pre and post LIFU application. The somatosensory pathway will be of most interest in analysis of the BOLD response.

Time frame: throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).

Data from ClinicalTrials.gov

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