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Neuromodulation
Low-Intensity Focused Ultrasound for Clinical Follow-up
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 outcomes assessed throughout participation - an average of 3 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trialexamines the effects of brain stimulation on muscle contractions to help improve addiction, pain and mental health. Participants have imaging scans and brain stimulation to temporarily affect activity. EMG records the muscle contractions.
Who is the study for?
This trial is for English-speaking individuals willing to use a medication monitoring system. It's not suitable for those with pacemakers, metal implants, history of significant head injury or substance dependence, active CNS-affecting medical conditions, pregnancy, or claustrophobia.
What is being tested?
The study tests how different durations of Low-Intensity Focused Ultrasound (LIFU) affect muscle contractions. Participants will undergo brain imaging and stimulation techniques while their muscle responses are recorded.
What are the potential side effects?
Potential side effects may include discomfort from the ultrasound device, temporary changes in brain activity that could influence mood or cognition, and possible skin irritation at the site of ultrasound application.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcomes assessed throughout participation - an average of 3 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcomes assessed throughout 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
Waveforms
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: Duration TrialsExperimental Treatment1 Intervention
Six different durations (three intermittent and three continuous) of LIFU application will be tested across six study sessions. Response recorded using TMS and EMG.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-Intensity Focused Ultrasound
2020
N/A
~10
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a head injury that made me unconscious for more than 10 minutes.I can speak and read English.I have a history of a neurological disorder.I have a condition or am on treatment that could affect my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Duration 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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