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

Trial statusNot yet recruiting
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

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) norms8

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, 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

  • Flicker Stimulation

    Behavioral

    Investigators will utilize 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.

  • 18 Hz Visual Occlusion

    Behavioral

    The participants will wear visual occlusion glasses with visible stimulation flickering at 18 Hz

  • Control - Visual Occlusion

    Behavioral

    Participants will receive visible stimulation at a frequency that is 1 Hz.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: ControlSham comparator 1 intervention
Group B: Flicker Stimulation - InfraredExperimental treatment 1 intervention
Group C: 18 Hz Visual OcclusionExperimental treatment 1 intervention
Group D: Control - Visual OcclusionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognition

Investigators will comprehensively assess behavior at three times (baseline, half-way through (1.5 months), and after the intervention (3months)) using the TabCAT. Composite Scores will serve as primary metrics for cognition.

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

Grip strength

Participants will grip a machine which measures their grip strength in kg.

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

10m Gait Speed

Participants will walk unassisted for 10 meters. Their speed will be measured in seconds.

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

Clinical Test of Sensory Interaction on Balance (CTSIB)

Participants will, with eyes open and closed, walk on rough and smooth terrain. Investigators will measure sway area (measured in m\^2/s\^4).

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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