Transcranial Focused Ultrasound for Neurocognitive Disorder

Overseen By Kevin Caulfield, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical University of South Carolina

Must not be taking: Anticholinergics, Sedatives

Disqualifiers: Substance use, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

25 Participants Needed

Trial Summary

What is the purpose of this trial?

Dementia is an ongoing and growing public health crisis in the US and worldwide. The purpose of this study is to examine a form of noninvasive brain stimulation called transcranial focused ultrasound (tFUS) to the hippocampus with the goal of improving memory.

Research Team

Kevin Caulfield, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adults aged 50-85 who speak English as their first language and have the ability to consent. It's aimed at those without a diagnosis of mild neurocognitive disorder (mNCD) or dementia, focusing on healthy aging individuals.

Inclusion Criteria

I am a healthy older adult.

I am between 50 and 85 years old.

I have not been diagnosed with major neurocognitive disorder or dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial focused ultrasound (tFUS) to the hippocampus to examine effects on memory

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Focused Ultrasound

Trial Overview The study is testing transcranial focused ultrasound (tFUS), a noninvasive brain stimulation targeting the hippocampus, with the aim of improving memory in both healthy older adults and those with mNCD.

Participant Groups

Group I: Focused Ultrasound to Location C Experimental Treatment 1 Intervention

Focused Ultrasound will be administered to location C as condition 3. Stimulation will last 1-10 minutes

Group II: Focused Ultrasound to Location B Experimental Treatment 1 Intervention

Focused Ultrasound will be administered to location B as condition 2. Stimulation will last 1-10 minutes

Group III: Focused Ultrasound to Location A Experimental Treatment 1 Intervention

Focused Ultrasound will be administered to location A as condition 1. Stimulation will last 1-10 minutes

Group IV: Focused Ultrasound to Location D Placebo Group 1 Intervention

Focused Ultrasound will be administered to location D as condition 4. Stimulation will last 1-10 minutes

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Center of Neuromodulation for Rehabilitation

Collaborator

Trials

12

Recruited

240+