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Device

Ultrasound Brain Stimulation for Anesthetic Sedation

Phase 2

Recruiting

Led By Zirui Huang

Research Sponsored by University of Michigan

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 up to 90 minutes

Awards & highlights

Study Summary

This trial will study if mental function occurs during different depths of anesthesia, and if using brain stimulation can help people return to consciousness faster.

Who is the study for?

This trial is for right-handed, English-speaking adults with a BMI under 30. It's not for those who can't have an MRI due to medical reasons, pregnancy, breastfeeding, certain tattoos, or metal in the body. People with learning disabilities, sleep apnea, GERD, recent food intake (within 8 hours), allergies to propofol/eggs/soy products or history of substance abuse are also excluded.Check my eligibility

What is being tested?

The study tests if ultrasonic brain stimulation (LIFUP) during anesthesia affects mental functions and speeds up waking up. Participants will undergo fMRI scans while receiving different levels of sedation with Propofol to monitor their brain activity.See study design

What are the potential side effects?

Potential side effects include discomfort from the ultrasound device on the head and reactions to Propofol such as nausea or dizziness. The MRI may cause claustrophobia or anxiety in some individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood Oxygen Level Dependent (BOLD) response to visual stimuli

Secondary outcome measures

Perceptual criterion derived from the Signal Detection Theory (SDT)

Sensitivity derived from the Signal Detection Theory (SDT)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Dorsolateral prefrontal cortex (DLPFC)Experimental Treatment2 Interventions

Group II: Central thalamus (CT)Experimental Treatment2 Interventions

Group III: Anterior insula cortex (AIC)Experimental Treatment2 Interventions

Group IV: Sham controlActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,796 Previous Clinical Trials

6,377,856 Total Patients Enrolled

Zirui HuangPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Ultrasonic Deep Brain Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05495945 — Phase 2

Mental Function Research Study Groups: Anterior insula cortex (AIC), Central thalamus (CT), Dorsolateral prefrontal cortex (DLPFC), Sham control

Mental Function Clinical Trial 2023: Ultrasonic Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05495945 — Phase 2

Ultrasonic Deep Brain Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05495945 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical research study?

"This research project is seeking 100 individuals aged 18-40 with healthy cognitive faculties. Additional requirements for participation include being right-handed, having a BMI below 30., and speaking English fluently."

Answered by AI

Is this experimental research open to participants under the age of 35?

"Prospective participants must meet the eligibility requirements, which stipulate that they are between 18 and 40 years old."

Answered by AI

How many subjects are being researched in this research endeavor?

"Affirmative, the details on clinicaltrials.gov ascertain that this experiment is actively recruiting volunteers. Originally posted in late August of 2022, it was last modified a few days later. The project seeks to enroll 100 individuals at one centre for participation."

Answered by AI

Do any risks exist in utilizing Propofol-enhanced fMRI scans?

"The safety rating of fMRI with Propofol was judged to be a 2 due to this being an early phase trial. There is some data validating its security, but no evidence confirming efficacy yet."

Answered by AI

Are further participants being sought for this investigation?

"Affirmative. The clinical trial data available on clinicaltrials.gov affirms that this medical study, originally posted on August 26th 2022, is actively seeking participants. One hundred individuals need to be enrolled from a single site in order for the trial to reach completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

Zirui Huang 2022. "Ultrasonic Deep Brain Stimulation During Anesthetic Sedation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05495945.