Study of Low-intensity Focused Ultrasound Effects on Human Memory

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT06628193
Status
Enrolling By Invitation

Conditions

  • Memory

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Low intensity focused ultrasound — DEVICE
    low-intensity focused ultrasound for neuromodulation applied to the head.
  • Sham (No Treatment) — DEVICE
    Sham LIFU application

Study Details

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.

Key Dates

Start date
Nov 18, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Sham Comparator: Sham LIFU
    Sham LIFU stimulation visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 1
    LIFU stimulation with parameter set 1 visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 2
    LIFU stimulation with parameter set 2 visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 3
    LIFU stimulation with parameter set 3 visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 4
    LIFU stimulation with parameter set 4 visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 5
    LIFU stimulation with parameter set 5 visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 6
    LIFU stimulation with parameter set 6 visit with memory tasks and neuropsychological assessments.
  • Experimental: LIFU 7
    LIFU stimulation with parameter set 7 visit with memory tasks and neuropsychological assessments.

Primary Outcome Measure

Memory Task Accuracy [ Time Frame: up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fralin Biomedical Research Institute at VTCRoanokeVirginia24016-

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Fralin Biomedical Research Institute at VTC· Roanoke, VA

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