Brief Summary

This research project is examining the effects of noninvasive brain stimulation on human memory. This study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in memory dysfunction. Subjects will undergo a magnetic resonance imaging (MRI) and a computed tomography (CT) scan, to take pictures of their brain and skull. They will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Their brain signals (MRI or EEG) will be monitored to measure changes in their brain signals. Their heart rate, blood pressure, respiratory rate, eye movement and skin moisture will be monitored as well. They will complete neuropsychological batteries and memory tasks. They will complete questionnaires.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

9mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

Study Progress70%

Nov 2024May 2027

First Submitted

Initial submission to the registry

September 23, 2024

Completed

11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

September 23, 2024

Last Update Submit

March 25, 2026

Conditions

Memory

Keywords

LIFU

Outcome Measures

Primary Outcomes (2)

Memory Task Accuracy
The percentage of correct responses during memory recall tasks, measured as a percentage. This metric will evaluate accuracy following LIFU stimulation compared to sham stimulation.
up to 6 weeks
Memory Task Reaction Time
Reaction time during memory recall tasks, measured in milliseconds. This metric will assess the speed of memory recall following LIFU stimulation compared to sham stimulation.
up to 6 weeks

Secondary Outcomes (5)

Electroencephalography(EEG) Power Spectral Analysis in Targeted Brain Regions
up to 6 weeks
Phase-Amplitude Coupling (PAC) Index
up to 6 weeks
Executive Function Score
up to 6 weeks
Attention Score
up to 6 weeks
Processing Speed Score
up to 6 weeks

Study Arms (8)

Sham LIFU

SHAM COMPARATOR

Sham LIFU stimulation visit with memory tasks and neuropsychological assessments.

Device: Sham (No Treatment)