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NCT Number: NCT07395609

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

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).

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Key information

Conditions

Subjective Cognitive Decline (SCD) Healthy Subjects

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

Location contact

Natalie C. Ebner, PhD

SUB_INVESTIGATOR

Rachael Seidler, PhD

CONTACT

[email protected]

734-834-0385

Rachael Seidler, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental -- 16.67 Hz Visual Occlusion

Behavioral

This group will wear visual occlusion glasses with visible stimulation at 16.67 Hz (corresponding to flicker of 32-36 Hz)

Control - 1Hz Visual Occlusion

Behavioral

This group will wear visual occlusion glasses with visible stimulation at 1 Hz

Primary outcomes

  1. Cognition - The Tablet-based Cognitive Assessment Tool (TabCAT)

    Time frame: 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.

  2. Mobility - Grip Strength

    Time frame: Baseline, 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.

  3. Mobility - 10 Meter Gait Speed

    Time frame: Baseline, 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.

  4. Mobility - Clinical Test of Sensory Interaction on Balance (CTSIB)

    Time frame: 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

  5. Affect - Profile of Mood States Second Edition (POMS-2)

    Time frame: 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.

  6. Affect - Ryff Scales of Psychological Wellbeing

    Time frame: Baseline, 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.

  7. Affect - Satisfaction with Life Scale

    Time frame: Baseline, 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.

  8. Brain Markers - Structure

    Time frame: Baseline, 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.

  9. AD Biomarkers - Amyloid

    Time frame: Baseline, 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.

  10. Biomarkers - P-Tau

    Time frame: Baseline, 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.

  11. Brain Markers - Network Function

    Time frame: Baseline, 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Hayes

CONTACT

[email protected]

(352) 273-2134

Sarah Verdecia-Zabala

CONTACT

[email protected]

(352) 273-2141

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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