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Focused Ultrasound
Transcranial Focused Ultrasound Safety in Healthy Subjects
N/A
Recruiting
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 2 years
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a device that uses focused ultrasound to study the brain and assess brain function. EEG readings also taken to observe changes in brain network activity.
Who is the study for?
This trial is for healthy adults aged 22-55 who speak English, can consent, and have no history of mental or physical illness. Women must not be pregnant and participants should not have metal implants. All must commit to the study schedule.Check my eligibility
What is being tested?
The study tests a device called Attune ATTN201 using Transcranial Focused Ultrasound (tFUS) on the Central Medial Thalamus in the brain to see how it affects sleep induction and brain activity without harming surrounding tissue.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from wearing the device, headache or dizziness post-treatment, changes in mood or cognitive function due to stimulation of brain areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of tFUS in healthy adults looking at retention and with a tFUS credibility questionnaire
Incidence of Adverse Events and Side Effects as assessed by Review of Systems Screener
Secondary outcome measures
Dose-response effects of tFUS on electroencephalographic (EEG) recordings
Effects of tFUS parameter alterations between part one and part two on electroencephalographic (EEG) recordings and behavior
Trial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Focused Ultrasound Dose #8Experimental Treatment1 Intervention
Focused Ultrasound will be administered using high frequency stimulation as condition 4. Stimulation will last 1-10 minutes.
Group II: Focused Ultrasound Dose #7Experimental Treatment1 Intervention
Focused Ultrasound will be administered using medium frequency stimulation as condition 4. Stimulation will last 1-10 minutes.
Group III: Focused Ultrasound Dose #6Experimental Treatment1 Intervention
Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.
Group IV: Focused Ultrasound Dose #3Experimental Treatment1 Intervention
Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.
Group V: Focused Ultrasound Dose #2Experimental Treatment1 Intervention
Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes.
Group VI: Focused Ultrasound Dose #1Experimental Treatment1 Intervention
Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes.
Group VII: Focused Ultrasound Dose #5Placebo Group1 Intervention
Focused Ultrasound will be administered using the sham condition.
Group VIII: Focused Ultrasound Dose #4Placebo Group1 Intervention
Focused Ultrasound will be administered using the sham condition.
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Who is running the clinical trial?
Attune NeurosciencesUNKNOWN
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,606 Total Patients Enrolled
Attune Neurosciences IncIndustry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot complete tests that measure my thinking skills.I have no history of major brain disorders or injuries.I am able to understand and agree to the study's requirements.I have epilepsy or seizures and am on medication that lowers my seizure threshold.I have taken mental health medication recently.I am not pregnant or capable of becoming pregnant.I have had a head injury that made me lose consciousness.I am between 22 and 55 years old.I am in good health with no history of serious illness or metal implants.I do not use drugs or certain medications regularly.The wearable device does not fit my head.
Research Study Groups:
This trial has the following groups:- Group 1: Focused Ultrasound Dose #5
- Group 2: Focused Ultrasound Dose #6
- Group 3: Focused Ultrasound Dose #7
- Group 4: Focused Ultrasound Dose #8
- Group 5: Focused Ultrasound Dose #1
- Group 6: Focused Ultrasound Dose #2
- Group 7: Focused Ultrasound Dose #3
- Group 8: Focused Ultrasound Dose #4
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 this medical trial open to individuals younger than 35?
"Eligibility for this clinical trial is contingent upon the age of participants, which must lie between 22 and 55."
Answered by AI
Are there any openings for volunteers in this experiment?
"Indeed, the information on clinicaltrials.gov indicates that this research study is presently recruiting participants. This medical trial was initially posted on July 1st 2023 and updated most recently on May 31st, 2023. The current objective is to find 10 individuals for a single site."
Answered by AI
What is the cap on participants for this clinical experiment?
"Affirmative. Based on the details posted to clinicaltrials.gov, this medical trial is in search of 10 volunteers and has been actively recruiting since July 1st 2023 with its latest edit occuring May 31st 2023 at a single site."
Answered by AI
Are there any stipulations to entering this clinical investigation?
"To be eligible to join this research initiative, potential volunteers must have a good bill of health and range in age from 22 to 55 years. Additionally, only 10 participants can take part in the study."
Answered by AI
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