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Investigation of Low-intensity Focused Ultrasound Pressure

Not Applicable
Conditions
Somatic Pain
Interventions
Device: low-intensity focused ultrasound - low pressure
Device: low-intensity focused ultrasound - medium pressure
Device: low-intensity focused ultrasound - high pressure
Registration Number
NCT06343883
Lead Sponsor
Virginia Polytechnic Institute and State University
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
25
Inclusion Criteria

Understand and speak English

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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
fMRIlow-intensity focused ultrasound - low pressureElectrical 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).
fMRIlow-intensity focused ultrasound - high pressureElectrical 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).
EEGlow-intensity focused ultrasound - medium pressureElectrical 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).
fMRIlow-intensity focused ultrasound - medium pressureElectrical 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).
EEGlow-intensity focused ultrasound - low pressureElectrical 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).
EEGlow-intensity focused ultrasound - high pressureElectrical 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).
Safety Check - high pressure applicationlow-intensity focused ultrasound - high pressureSmall 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.
Primary Outcome Measures
NameTimeMethod
MRIpre and post intervention in cohort 1

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

Report of Symptoms Questionnairepre/post intervention and 1 week post intervention.

questionnaire of symptomology administered pre and post intervention.

Secondary Outcome Measures
NameTimeMethod
EEGthroughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).

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

fMRIthroughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).

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.

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC

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Roanoke, Virginia, United States

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