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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-89
SponsorUniversity of Florida

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Community dwelling men and women 65-89 years old

Ability to walk unassisted for 10 min

English speaking Additional Inclusion Criteria for SCD

No evidence of dementia or MCI based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms

Disqualifiers

If participants score less than 21 on the Telephone Interview for Cognitive Status (TICS)

Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.)

Severe visual impairment or corrected visual acuity less than 20/40 (as per self-report), which would preclude completion of assessments

Inability to undergo MRI brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, certain non-removable body jewelry, or shrapnel containing ferromagnetic metal

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental -- 16.67 Hz Visual Occlusion

    Behavioral

    This group will wear visual occlusion glasses with visible stimulation at 16.67 Hz (corresponding to flicker of 32-36 Hz)

  • Control - 1Hz Visual Occlusion

    Behavioral

    This group will wear visual occlusion glasses with visible stimulation at 1 Hz

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ControlSham comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cognition - The Tablet-based Cognitive Assessment Tool (TabCAT)

This test battery assesses performance in various cognitive components. A composite score across subtasks will be computed. Higher scores in the composite indicates better cognition.

Time frame
Baseline, halfway through (1.5 months), and post-intervention (3 months)
2

Mobility - Grip Strength

This test assesses grip strength in kg. A composite score across trials will be computed. Higher scores indicate more strength.

Time frame
Baseline, halfway through (1.5 months), and post-intervention (3 months)
3

Mobility - 10 Meter Gait Speed

This test assesses speed in seconds during unassisted walking for 10 meters. A composite score across trials will be computed. Higher scores indicate lower walking speed.

Time frame
Baseline, halfway through (1.5 months), and post-intervention (3 months)
4

Mobility - Clinical Test of Sensory Interaction on Balance (CTSIB)

This test assesses sway area (measured in m\^2/s\^4) with eyes open and closed while standing on a hard and a foam surface. A larger sway area indicates greater postural instability and poorer balance control during specific sensory conditions

Time frame
Baseline, halfway through (1.5 months), and post-intervention (3 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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