Study of Low-intensity Focused Ultrasound Effects on Human Memory
March 25, 2026 updated by: Wynn Legon, Virginia Polytechnic Institute and State University
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
This study employs a two-arm, sham-controlled, repeated measures design conducted across eight sessions:
Overall Structure
- Session 1: Baseline Assessment and Imaging
- Session 2-8: LIFU Stimulation *The order of Sessions 2-8 is ideally randomized to control for order effects. The study design allows for flexibility to accommodate varying levels of participant completion while maintaining scientific validity.
Detailed Session Breakdown Session 1: Baseline Assessment and Imaging
- Structural & Functional imaging: MRI and CT anatomical scans
- Administration of questionnaire battery Session 2-8: LIFU Stimulation or Sham
- Memory task performance
- Neuropsychological battery administration
- EEG recording
- Collection of physiological measures (HR, BP, RR, and EDR)
Design Considerations: There will be at least one week between Session 1 and Session 2, and at least 48 hours between each subsequent session. This design allows for within-subject comparisons across stimulation conditions, as well as between-subject comparisons if the full protocol is completed. The study protocol is designed to accommodate potential variability in participant availability. While full completion of all sessions is ideal, partial completion can still yield valuable data.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute at VTC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subjects of all ethnicities, who understand and speak English.
Exclusion Criteria:
The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- History of head injury resulting in loss of consciousness for >10 minutes.
- History of alcohol or drug dependence (through self-report).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham LIFU
Sham LIFU stimulation visit with memory tasks and neuropsychological assessments.
|
Sham LIFU application
|
|
Experimental: LIFU 1
LIFU stimulation with parameter set 1 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
|
Experimental: LIFU 2
LIFU stimulation with parameter set 2 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
|
Experimental: LIFU 3
LIFU stimulation with parameter set 3 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
|
Experimental: LIFU 4
LIFU stimulation with parameter set 4 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
|
Experimental: LIFU 5
LIFU stimulation with parameter set 5 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
|
Experimental: LIFU 6
LIFU stimulation with parameter set 6 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
|
Experimental: LIFU 7
LIFU stimulation with parameter set 7 visit with memory tasks and neuropsychological assessments.
|
low-intensity focused ultrasound for neuromodulation applied to the head.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory Task Accuracy
Time Frame: up to 6 weeks
|
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
Time Frame: up to 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electroencephalography(EEG) Power Spectral Analysis in Targeted Brain Regions
Time Frame: up to 6 weeks
|
Change in theta power (4 - 8 HZ) and gamma power (30 - 100 HZ) measured by up to 64-channel EEG systems within targeted brain regions, measured in microvolts squared (uV2).
This outcome will assess alterations in brain electrical activities during memory tasks.
|
up to 6 weeks
|
|
Phase-Amplitude Coupling (PAC) Index
Time Frame: up to 6 weeks
|
Change in the strength of phase-amplitude coupling between theta and gamma oscillations measured by up to 64-channel electroencephalography (EEG) systems, expressed as a coupling index (unitless ration).
This outcome will provide insights into neural connectivity alterations during memory tasks.
|
up to 6 weeks
|
|
Executive Function Score
Time Frame: up to 6 weeks
|
Executive function will be assessed using standardized tools form NIH Toolbox Cognitive Battery, with results expressed as T-scores.
|
up to 6 weeks
|
|
Attention Score
Time Frame: up to 6 weeks
|
Attention will be measured through the NIH Toolbox Cognitive Battery, with results provided in T-scores
|
up to 6 weeks
|
|
Processing Speed Score
Time Frame: up to 6 weeks
|
Processing speed will be evaluated using the NIH Toolbox Cognitive Battery with scores expressed as T-scores.
|
up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
September 23, 2024
First Submitted That Met QC Criteria
October 2, 2024
First Posted (Actual)
October 4, 2024
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24-999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.