Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 9:47 AM
Study NCT ID:
NCT06628193
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-17
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Low-intensity Focused Ultrasound Effects on Human Memory
Sponsor:
Virginia Polytechnic Institute and State University
Organization:
Study Overview
Official Title:
Study of Low-intensity Focused Ultrasound Effects on Human Memory
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: