Subjective Cognitive Decline (SCD)NCT07395609
High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Without Subjective Cognitive Decline
A study testing Experimental -- 16.67 Hz Visual Occlusion in people with Subjective Cognitive Decline (SCD) and Healthy Subjects, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline (SCD), Healthy Subjects
- What is being tested?
- Experimental -- 16.67 Hz Visual Occlusion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2026to 31 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Rachael Seidler, PhD, 734-834-0385, rachaelseidler@ufl.edu
natalie.ebner@ufl.edu
About this study
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).
- Being tested
- Experimental -- 16.67 Hz Visual Occlusion, Control - 1Hz Visual Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental -- 16.67 Hz Visual OcclusionBehavioural
This group will wear visual occlusion glasses with visible stimulation at 16.67 Hz (corresponding to flicker of 32-36 Hz)
Control - 1Hz Visual OcclusionBehavioural
This group will wear visual occlusion glasses with visible stimulation at 1 Hz
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Participants in this group will receive the control stimulation at the slower rate. Receives: Behavioral: Control - 1Hz Visual Occlusion |
| Experimental | Experimental | Participants in this group will receive the experimental stimulation at the faster rate. Receives: Behavioral: Experimental -- 16.67 Hz Visual Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Mobility - Grip Strength
This test assesses grip strength in kg. A composite score across trials will be computed. Higher scores indicate more strength.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
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.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
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
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Affect - Profile of Mood States Second Edition (POMS-2)
This questionnaire assesses transient feelings and mood on a scale from 0 = not at all to 4 = extremely). A composite score across items will be computed as primary outcome. Higher scores indicate greater intensity of the mood state.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Affect - Ryff Scales of Psychological Wellbeing
This questionnaire assesses psychological well-being via 42 statements using a 6-point scale (1 = strongly agree; 6 = strongly disagree). A composite score across items will be computed as primary outcome. Higher scores indicate greater psychological wellbeing.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Affect - Satisfaction with Life Scale
This questionnaire assesses satisfaction with life. A composite score across items will be computed as primary outcome. The possible range of scores is 5-35. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. A composite score across items will be computed as primary outcome. Higher scores indicate greater life satisfaction.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Brain Markers - Structure
Cortical thickness (in mm) will be determined via a T1 MRI scan in dorsolateral prefrontal, sensorimotor, and insular cortices using the CAT computational anatomy toolbox. Greater values indicate greater cortical thickness.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
AD Biomarkers - Amyloid
These assays will determine amyloid (e.g., Aβ17) sensitive to Alzheimer's Disease. Higher values indicate higher amyloid levels.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Biomarkers - P-Tau
These assays will determine p-tau levels sensitive to Alzheimer's Disease. A composite score across items will be computed as primary outcome. Higher values indicate higher p-tau levels.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Brain Markers - Network Function
Brain network function will be assessed via resting-state fMRI (in Blood oxygen level dependent response) to capture functional segregation of dorsolateral prefrontal, sensorimotor, and insular networks using the CONN toolbox. Greater values indicate greater functional connectivity.
Measured: Baseline, halfway through (1.5 months), and post-intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start14 Aug 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachael C. Seidler, Principal investigator, University of FloridaNatalie C. Ebner, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395609
- Sponsor's protocol ID
- IRB202500587
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon study completion, published data will be made available via established repositories (e.g., NIH OpenNeuro, OSF).