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

Overview

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).

Interventions

• Behavioral Experimental -- 16.67 Hz Visual Occlusion
  This group will wear visual occlusion glasses with visible stimulation at 16.67 Hz (corresponding to flicker of 32-36 Hz)
• Behavioral Control - 1Hz Visual Occlusion
  This group will wear visual occlusion glasses with visible stimulation at 1 Hz

Primary outcome measures

• Cognition - The Tablet-based Cognitive Assessment Tool (TabCAT) [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Mobility - Grip Strength [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Mobility - 10 Meter Gait Speed [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Mobility - Clinical Test of Sensory Interaction on Balance (CTSIB) [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Affect - Profile of Mood States Second Edition (POMS-2) [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Affect - Ryff Scales of Psychological Wellbeing [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Affect - Satisfaction with Life Scale [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Brain Markers - Structure [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• AD Biomarkers - Amyloid [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]
• Biomarkers - P-Tau [Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)]

Eligibility criteria

Inclusion criteria

• 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
• Global Clinic Dementia Rating (CDR) score must be 0 or 0.531
• Subjective report of cognitive complaints with scores >20 on the Cognitive Change Index (CCI-20), a validated scale of subjective cognitive decline6; this scale consists of 20 items that are rated on a 5-point Likert scale, where 1= "Normal: No change compared to 5 years ago", 3= "Mild Problem: Some change compared to 5 years ago) and 5="Severe Problem: Much worse compared to 5 years ago"
• Family history of dementia/probable AD in first degree relative (parents, children, siblings)
• Normal functional behavior in terms of daily activities, based on the Functional Activities Scale In line with recommendations of the SCD task force an informant must be available for two reasons: a) to provide information about the participant's cognition using the informant version of the CDR and CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire (informant data will be collected via a phone call and linked by code with the participant data).

Exclusion criteria

• 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
• History of severe stroke
• Epilepsy or family history of epilepsy, past seizure history, as well as history of migraines
• Current use of psychotropic medications
• Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer)
• Report of lower extremity pain due to osteoarthritis that significantly limits mobility
• Diagnosis or treatment for rheumatoid arthritis
• Known neuromuscular disorder or overt neurological disease (e.g., Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.)
• Unable to communicate because of severe hearing loss or speech disorder
• Planned surgical procedure or hospitalization in the next 4 months (joint replacement, coronary artery bypass graft, etc.)
• Severe pulmonary disease, requiring the use of supplemental oxygen
• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
• Use of walker or wheelchair

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Florida — Gainesville

Identifiers

NCT: NCT07395609 · IRB202500587

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗