High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Without Subjective Cognitive Decline

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07395609
Status
Not Yet Recruiting

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Conditions

  • Healthy Subjects
  • Subjective Cognitive Decline (SCD)

Eligibility Criteria

Sex
ALL
Age
65 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Flicker Stimulation — BEHAVIORAL
    Investigators will combine ultrasound (≥22 kHz) and near-infrared two-photon stimulation (890-940 nm) to deliver rhythmic input in a subliminal, comfortable manner, without the side effects associated with visible flicker.
  • Control Stimulation — BEHAVIORAL
    The control group will receive a control stimulation rather than a constant flicker frequency.
  • 40 Hz Visual Occlusion — BEHAVIORAL
    Participant will wear visual occlusion glasses with visible stimulation flickering at 40 Hz
  • Control - Visual Occlusion — BEHAVIORAL
    Participants will receive visible stimulation at a frequency that is not 40 Hz.

Study Details

The goal is to determine whether three months of at least three times / week of sensory flicker stimulation improves cognition, mobility, and affect in healthy older adults and older adults with and without Subjective Cognitive Decline (SCD). Investigators will also determine whether the intervention slows cortical thinning and declines in brain functional network segregation and changes in blood biomarkers of Alzheimer's Disease (AD).

Key Dates

Start date
Jun 30, 2026
Status verified
Aug 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Sham Comparator: Control
    Participants in this group will receive control stimulation rather than a constant flicker frequency.
  • Experimental: Flicker Stimulation - Infrared
    Participants in this group will receive infrared sensory visual flicker stimulation.
  • Experimental: 40 Hz Visual Occlusion
    Participants will wear visual occlusion glasses with visible flickering.
  • Sham Comparator: Control - Visual Occlusion
    Participants will receive visual stimulation at a control frequency that is not 40 Hz

Primary Outcome Measure

Cognition [ Time Frame: Baseline, halfway through (1.5 months), and post-intervention (3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Rachael Seidler
[email protected]
734-834-0385

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FL

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