Investigation of Low-intensity Focused Ultrasound Pressure
- Conditions
- Somatic Pain
- Interventions
- Device: low-intensity focused ultrasound - low pressureDevice: low-intensity focused ultrasound - medium pressureDevice: low-intensity focused ultrasound - high pressure
- Registration Number
- NCT06343883
- 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
Understand and speak English
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- History of head injury resulting in loss of consciousness for >10 minutes.
- History of alcohol or drug dependence (through self-report).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description fMRI low-intensity focused ultrasound - low pressure 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). fMRI low-intensity focused ultrasound - high pressure 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). EEG low-intensity focused ultrasound - medium pressure 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). fMRI low-intensity focused ultrasound - medium pressure 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). EEG low-intensity focused ultrasound - low pressure 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). EEG low-intensity focused ultrasound - high pressure 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). Safety Check - high pressure application low-intensity focused ultrasound - high pressure 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.
- Primary Outcome Measures
Name Time Method MRI pre 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 Questionnaire pre/post intervention and 1 week post intervention. questionnaire of symptomology administered pre and post intervention.
- Secondary Outcome Measures
Name Time Method EEG throughout 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.
fMRI throughout 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
🇺🇸Roanoke, Virginia, United States