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Focused Ultrasound for Healthy Subjects
N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate post-stimulation
Awards & highlights
Study Summary
This trial studies how sound waves can affect brain signals and chemicals to understand neurological conditions.
Who is the study for?
This trial is for healthy men and women aged 18-55 who speak English as their primary language. Participants must not be pregnant, have no history of mental or physical illness, no metal implants, and cannot have a personal or family history of seizures or epilepsy. They should not be on psychotropic medications recently nor have any substance abuse issues.Check my eligibility
What is being tested?
The study is examining the safety and effects of Transcranial Focused Ultrasound (tFUS) on motor functions by measuring Motor Evoked Potentials (MEPs) and monitoring GABA and Glutamate concentrations in the brain among healthy individuals.See study design
What are the potential side effects?
As this trial involves healthy subjects with non-invasive stimulation, side effects are expected to be minimal but may include discomfort at the site of ultrasound application or temporary changes in motor function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate post-stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate post-stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor Evoked Potential Amplitude
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Inhibitory tFUS parameters effect of Motor Evoked PotentialsExperimental Treatment1 Intervention
All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 5% duty cycle
Group II: Excitatory tFUS parameters effect on Motor Evoked PotentialsExperimental Treatment1 Intervention
All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 50% duty cycle.
Group III: Sham tFUS parameters effect of Motor Evoked PotentialsPlacebo Group1 Intervention
All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will utilize an air-filled spacer to block stimulation from reaching the brain
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,365 Total Patients Enrolled
BRAINBox Solutions IncIndustry Sponsor
1 Previous Clinical Trials
2,000 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I or someone in my family has had a neurological illness or injury.I am in good health with no history of serious illness or metal implants.I am between 18 and 55 years old.I have taken mental health medication within a certain time before the procedure.I am currently diagnosed with or being treated for a mental health condition.I am either male or female.I am able to understand and agree to the study's procedures and risks.I was diagnosed with COVID-19 in the last two weeks.I or someone in my family has had seizures or epilepsy.I am not pregnant or capable of becoming pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Excitatory tFUS parameters effect on Motor Evoked Potentials
- Group 2: Inhibitory tFUS parameters effect of Motor Evoked Potentials
- Group 3: Sham tFUS parameters effect of Motor Evoked Potentials
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range of participants in this trial limited to those younger than 55?
"This medical trial only allows individuals between 18 and 55 to participate. For those below or above this age range, there are separate trials that might be more suited: 55 studies for minors and 372 for seniors."
Answered by AI
Is there still an opportunity for individuals to partake in this experiment?
"No, this research is no longer actively enrolling patients. It was originally posted in June 2023 and the most recent update occured in March of that year. However, there are currently 827 other trials searching for volunteers at this time."
Answered by AI
What qualifications must an individual possess to be eligible for this clinical experiment?
"Participants in this trial should be between 18-55 years of age and overall healthy. Approximately 25 individuals are currently being invited to join the experiment."
Answered by AI
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