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Enrolling by Invitation

NCT Number: NCT06628193

Study of Low-intensity Focused Ultrasound Effects on Human Memory

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.

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Key information

Conditions

Memory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low Intensity Focused Ultrasound

Device

low-intensity focused ultrasound for neuromodulation applied to the head.

Sham (No Treatment)

Device

Sham LIFU application

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Attention Score

    Time frame: up to 6 weeks

    Attention will be measured through the NIH Toolbox Cognitive Battery, with results provided in T-scores

  5. 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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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