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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 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

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Investigators will assess behavior at three times (baseline, half-way through (1.5 months), and after the intervention (3 months)) using the TabCAT. Composite Scores will serve as primary metrics for cognition.

  2. Grip strength

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Participants will grip a machine which measures their grip strength in kg.

  3. 10m Gait Speed

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Participants will walk unassisted for 10 meters. Their speed will be measured in seconds.

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

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Participants will, with eyes open and closed, walk on rough and smooth terrain. Investigators will measure sway area (measured in m^2/s^4).

  5. Affect - POMS-2

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    This test is used to assess transient feelings and mood among individuals aged 13 years and above.

    Scoring:

    0 - Not at all

    • - A little
    • - Moderately
    • - Quite a Lot
    • - Extremely

    Except "Relaxed" and "Efficient", and they score the reverse:

  6. Affect - Ryff Scales of Psychological Wellbeing

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Respondents agree or disagree with 42 statements using a 6-point scale (1 = strongly agree; 6 = strongly disagree).

  7. Affect - Satisfaction with Life Scale

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    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.

  8. Affect - Perceived Stress Scale

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Score is obtained by reverse-scoring items 4, 5, 7, and 8 and then summing the scores.

  9. Affect - Apathy Evaluation Scale

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    After recoding all necessary items, sum up all scores.

  10. Affect - TabCAT Dynamic Affect Recognition Test (DART) task

    Time frame: Baseline, midpoint (1.5 months), and post-intervention (3 months)

    The examinee is shown videos depicting realistic non-verbal emotional cues, and is asked to identify the emotion that the character displayed in the video.

  11. Affect - TabCAT Social Interaction Vocabulary Test (SIVT) task

    Time frame: Baseline, midpoint (1.5 months), and post-intervention (3 months)

    The examinee is given a word describing a socioemotional interaction and is asked to choose a picture that best represents the meaning of the word.

  12. Brain Structure and Network Function

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Investigators will assess brain structure via a T1 MRI to measure cortical thickness in dorsolateral prefrontal, sensorimotor, and insular cortices using the CAT computational anatomy toolbox; brain network function via resting-state fMRI to capture functional segregation of dorsolateral prefrontal, sensorimotor, and insular networks (subserving cognition, mobility, and affect respectively) using the CONN toolbox.

  13. Blood-based AD pathology (Aβ17)

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Investigators will assess levels of Aβ17 [units], which is sensitive to AD. Blood samples will be processed on campus by UF's Florida Alzheimer's Disease Research Center Biomarker Core. Blood will be centrifuged and placed into -80°C storage maintained by the PIs. Coded blood samples will be analyzed in the final year of this project. These biomarker levels will not be shared with participants, as this is not a diagnostic laboratory.

  14. Blood-based AD pathology [p-tau]

    Time frame: Baseline, halfway through (1.5 months), and post-intervention (3 months)

    Investigators will assess levels of p-tau [units], which is sensitive to AD. Blood samples will be processed on campus by UF's Florida Alzheimer's Disease Research Center Biomarker Core. Blood will be centrifuged and placed into -80°C storage maintained by the PIs. Coded blood samples will be analyzed in the final year of this project. These biomarker levels will not be shared with participants, as this is not a diagnostic laboratory.

Study contacts

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

Natalie C. Ebner, PhD

CONTACT

[email protected]

2035910371

Rachael Seidler, PhD

CONTACT

[email protected]

7348340385

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
Jul 27, 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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