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

Recruiting now · Not applicable

Conditions studied: Subjective Cognitive Decline (SCD), Healthy Subjects

In brief

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 facts

Study ID: NCT07395609
Run by: University of Florida
People needed: 60
Starts: 2026-08-03
Expected to finish: 2028-10-31
Last updated by the study team: 2026-08-03

Who can join

Age: 65 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

University of Florida — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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