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

{ "High Frequency Stimulation for Cognition and Mobility", "This study is looking at whether a special type of light stimulation can improve memory, thinking skills (cognition), movement (mobility), and mood in older adults. You might be able to join if you are between 65 and 89 years old, can walk without help, and speak English. This includes healthy older adults and those who feel their memory is declining (Subjective Cognitive Decline or SCD). Participants will wear special glasses that flicker at either 16.67 Hz (experimental group) or 1 Hz (control group) for three months, at least three times a week. Researchers will measure changes in your cognition, grip strength, and walking speed to see if the stimulation helps. The current status of this study is unclear.", "design": "This study is an interventional trial planning to enroll 60 participants. It compares two groups: one receiving 16.67 Hz Visual Occlusion and another receiving 1 Hz Visual Occlusion.", "commitments": "You would participate in sensory flicker stimulation at least three times a week for three months. Your cognition, grip strength, and walking speed will be measured at the start, halfway through (1.5 months), and at the end of the intervention (3 months).", "compensation": "Not stated in the trial record.", "follow_up": "Your cognition, grip strength, and walking speed will be measured at the end of the 3-month intervention period.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07395609

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

Recruiting
NAAges 65–89InterventionalBasic science
University of Florida
~60 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Experimental -- 16.67 Hz Visual OcclusionControl - 1Hz Visual Occlusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cognition - The Tablet-based Cognitive Assessment Tool (TabCAT)
Measured over Baseline, halfway through (1.5 months), and post-intervention (3 months)
+10 more outcomes measured
Subjective Cognitive Decline (SCD)
Healthy Subjects
1 sites across 1 states
Florida1
  • Rachael C. Seidler · PRINCIPAL_INVESTIGATOR · University of Florida
  • Natalie C. Ebner, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

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Eligibility criteria

Inclusion

Community dwelling men and women 65-89 years old
Ability to walk unassisted for 10 min
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

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
  • Cognition - The Tablet-based Cognitive Assessment Tool (TabCAT)Baseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • Mobility - Grip StrengthBaseline, halfway through (1.5 months), and post-intervention (3 months)

    This test assesses grip strength in kg. A composite score across trials will be computed. Higher scores indicate more strength.

  • Mobility - 10 Meter Gait SpeedBaseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • Mobility - Clinical Test of Sensory Interaction on Balance (CTSIB)Baseline, halfway through (1.5 months), and post-intervention (3 months)

    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

  • Affect - Profile of Mood States Second Edition (POMS-2)Baseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • Affect - Ryff Scales of Psychological WellbeingBaseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • Affect - Satisfaction with Life ScaleBaseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • Brain Markers - StructureBaseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • AD Biomarkers - AmyloidBaseline, halfway through (1.5 months), and post-intervention (3 months)

    These assays will determine amyloid (e.g., Aβ17) sensitive to Alzheimer's Disease. Higher values indicate higher amyloid levels.

  • Biomarkers - P-TauBaseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  • Brain Markers - Network FunctionBaseline, halfway through (1.5 months), and post-intervention (3 months)

    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.