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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 89
Healthy Volunteers: t
View:

• 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).

Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Alyssa Hayes
alyssa.hayes@ufl.edu
(352) 273-2134
Backup
Sarah Verdecia-Zabala
sverdeciazabala@ufl.edu
(352) 273-2141
Time Frame
Start Date: 2026-08-14
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 60
Treatments
Sham_comparator: Control
Participants in this group will receive the control stimulation at the slower rate.
Experimental: Experimental
Participants in this group will receive the experimental stimulation at the faster rate.
Related Therapeutic Areas
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov