Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Not Applicable

• Conditions: Chronic Pain
• Interventions: Device: Low Intensity Focused Ultrasound

• Registration Number: NCT05145426
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

This project examines the effects of noninvasive brain stimulation on pain. The investigators believe this study will help to better understand possible treatments for chronic pain patients. 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) device which uses sound waves to temporarily change brain activity. Pain testing is done using a small device that will increase/decrease the temperature of the skin. Brain signals are collected using electroencephalography (EEG). Heart rate, blood pressure, and skin moisture will be monitored as well.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-06
• Study Start: 2022-02-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

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

Inclusion Criteria

• Understand and speak English

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Exclusion Criteria

• MRI/CT/EEG contraindications.

  1. Claustrophobia
  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
  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 Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain Trials	Low Intensity Focused Ultrasound	Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).

Primary Outcome Measures

Name	Time	Method
Perceived sensation score	Assessed per participant, over the course of participation - an average of 3 weeks.	Changed perceived sensation score on a 1-10 scale in response to painful stimuli.

Secondary Outcome Measures

Name	Time	Method
Windup Pain	Assessed per participant, over the course of participation - an average of 3 weeks	Changed windup pain score on a 1-10 scale.
CHEP Amplitude	Assessed per participant, over the course of participation - an average of 3 weeks	Attenuated N1/P1 CHEP amplitude recorded with EEG

Trial Locations

Locations (1)

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