Investigation of Low-intensity Focused Ultrasound Parameters

Not Applicable

Completed

• Conditions: Development of LIFU for Clinical Purposes
• Interventions: Device: Low-intensity Focused Ultrasound

• Registration Number: NCT05134233
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-11-24
• Study Start: 2022-01-14
• Status Verified: 2024-03
• Primary Completion: 2024-03-11
• Study Completion: 2024-03-11
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Above criteria and must understand and speak English.

Read More

Exclusion Criteria

• Contraindications to MRI, CT, or TMS

  1. Claustrophobia
  2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for >10 minutes
  7. History of alcohol or drug dependence
  8. Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parameter Trials	Low-intensity Focused Ultrasound	Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG.

Primary Outcome Measures

Name	Time	Method
Waveforms	Outcome measured throughout study participation - an average of 4 weeks per participant.	Changes in waveform peak will be observed per each variable application of LIFU

Trial Locations

Locations (1)

Fralin Biomedical Research Institute; 🇺🇸 Roanoke, Virginia, United States