MemoryNCT06628193
Study of Low-intensity Focused Ultrasound Effects on Human Memory
A study testing Low intensity focused ultrasound in people with Memory, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory
- What is being tested?
- Low intensity focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of all ethnicities, who understand and speak English.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
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.
Read the 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.
- Conditions
- Memory
- Being tested
- Low intensity focused ultrasound, Sham (No Treatment)
- Keywords
- LIFU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity focused ultrasoundDevice
low-intensity focused ultrasound for neuromodulation applied to the head.
Sham (No Treatment)Device
Sham LIFU application
| Study group | Role | What they receive |
|---|---|---|
| Sham LIFU | Sham comparator | Sham LIFU stimulation visit with memory tasks and neuropsychological assessments. Receives: Device: Sham (No Treatment) |
| LIFU 1 | Experimental | LIFU stimulation with parameter set 1 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
| LIFU 2 | Experimental | LIFU stimulation with parameter set 2 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
| LIFU 3 | Experimental | LIFU stimulation with parameter set 3 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
| LIFU 4 | Experimental | LIFU stimulation with parameter set 4 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
| LIFU 5 | Experimental | LIFU stimulation with parameter set 5 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
| LIFU 6 | Experimental | LIFU stimulation with parameter set 6 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
| LIFU 7 | Experimental | LIFU stimulation with parameter set 7 visit with memory tasks and neuropsychological assessments. Receives: Device: Low intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 6 weeks
Secondary outcomes (5)
Electroencephalography(EEG) Power Spectral Analysis in Targeted Brain Regions
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.
Measured: up to 6 weeks
Phase-Amplitude Coupling (PAC) Index
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.
Measured: up to 6 weeks
Executive Function Score
Executive function will be assessed using standardized tools form NIH Toolbox Cognitive Battery, with results expressed as T-scores.
Measured: up to 6 weeks
Attention Score
Attention will be measured through the NIH Toolbox Cognitive Battery, with results provided in T-scores
Measured: up to 6 weeks
Processing Speed Score
Processing speed will be evaluated using the NIH Toolbox Cognitive Battery with scores expressed as T-scores.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start18 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- sham-controlled, repeated measures design conducted across eight sessions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynn Legon, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628193
- Sponsor's protocol ID
- 24-999
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Low-intensity Focused Ultrasound Effects on Human Memory
- ClinicalTrials.gov ID
- NCT06628193
- Acronym / sponsor ID
- 24-999
- Conditions
- Memory
- Keywords
- LIFU
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- sham-controlled, repeated measures design conducted across eight sessions
| Arm | Type | Receives |
|---|---|---|
| Sham LIFU | Sham comparator | Device: Sham (No Treatment)Sham LIFU stimulation visit with memory tasks and neuropsychological assessments. |
| LIFU 1 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 1 visit with memory tasks and neuropsychological assessments. |
| LIFU 2 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 2 visit with memory tasks and neuropsychological assessments. |
| LIFU 3 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 3 visit with memory tasks and neuropsychological assessments. |
| LIFU 4 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 4 visit with memory tasks and neuropsychological assessments. |
| LIFU 5 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 5 visit with memory tasks and neuropsychological assessments. |
| LIFU 6 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 6 visit with memory tasks and neuropsychological assessments. |
| LIFU 7 | Experimental | Device: Low intensity focused ultrasoundLIFU stimulation with parameter set 7 visit with memory tasks and neuropsychological assessments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects of all ethnicities, who understand and speak English.
Key exclusion criteria (8 listed)
- The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity focused ultrasoundlow-intensity focused ultrasound for neuromodulation applied to the head. | Device | LIFU 1, LIFU 2, LIFU 3, LIFU 4, LIFU 5, LIFU 6, LIFU 7 |
| Sham (No Treatment)Sham LIFU application | Device | Sham LIFU |
Primary outcome
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.
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.
5 secondary outcomes
Electroencephalography(EEG) Power Spectral Analysis in Targeted Brain Regions
Time frame: up to 6 weeks
Phase-Amplitude Coupling (PAC) Index
Time frame: up to 6 weeks
Executive Function Score
Time frame: up to 6 weeks
Attention Score
Time frame: up to 6 weeks
Processing Speed Score
Time frame: up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound in people with Memory, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory Task Accuracy (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.