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Low-intensity Focused Ultrasound for Chronic Pain
N/A
Waitlist Available
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed per participant, over the course of participation - an average of 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a device that uses sound waves can help to treat chronic pain by temporarily changing brain activity. Brain signals, heart rate, blood pressure, and skin moisture will be monitored during the trial.
Who is the study for?
This trial is for English-speaking individuals with chronic pain. It's not suitable for those who have contraindications to MRI/CT/EEG, claustrophobia, certain implants like pacemakers or cochlear implants, pregnant women, people with active medical disorders affecting the brain, a history of significant head injury or substance dependence.
What is being tested?
The study tests Low Intensity Focused Ultrasound (LIFU) as a noninvasive treatment for chronic pain. Participants will undergo imaging tests and have their brain activity altered by sound waves while their physiological responses are monitored.
What are the potential side effects?
Potential side effects may include discomfort from temperature changes on the skin during pain testing and possible temporary changes in brain activity due to LIFU. Monitoring includes heart rate, blood pressure, and skin moisture.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed per participant, over the course of participation - an average of 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed per participant, over the course of participation - an average of 3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Perceived sensation score
Secondary study objectives
CHEP Amplitude
Windup Pain
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pain TrialsExperimental Treatment1 Intervention
Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
153 Previous Clinical Trials
25,025 Total Patients Enrolled
4 Trials studying Chronic Pain
142 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that makes it unsafe for you to have an MRI, CT scan, or EEG.You have a history of a brain or nerve disorder.You have had a head injury where you were unconscious for more than 10 minutes.You have a history of being dependent on alcohol or drugs.You are afraid of being in small or enclosed spaces.You cannot have an MRI if you have a pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in your eyes, work with steel, or have other implants that are not compatible with MRI.You cannot participate if you are pregnant and a CT scan is not recommended for you.You have a medical condition or are taking medication that can affect your brain.
Research Study Groups:
This trial has the following groups:- Group 1: Pain Trials
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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