Investigation of Low-intensity Focused Ultrasound Pressure

Not Applicable

• Conditions: Somatic Pain

• 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.

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-03
• Study Start: 2024-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

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