Investigation of the Duration of Low-intensity Focused Ultrasound

Not Applicable

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

• Registration Number: NCT05147103
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

This project examines the effects of various durations of noninvasive neuromodulation 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, a functional Magnetic Resonance Image (fMRI) and computed tomography (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 of the hand.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-07
• Study Start: 2022-08-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Above criteria and must understand and speak English.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duration Trials	Low-Intensity Focused Ultrasound	Six different durations (three intermittent and three continuous) of LIFU application will be tested across six study sessions. Response recorded using TMS and EMG.

Primary Outcome Measures

Name	Time	Method
Waveforms	Outcomes assessed throughout participation - an average of 3 weeks.	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