Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628193
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Study of Low-intensity Focused Ultrasound Effects on Human Memory
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Low-intensity Focused Ultrasound Effects on Human Memory
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 amp 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 amp 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None