High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Wit… (NCT07395609) | Clinical Trial Compass
RecruitingNot Applicable
High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Without Subjective Cognitive Decline
United States60 participantsStarted 2026-08-03
Plain-language 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).
Who can participate
Age range
65 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognition - The Tablet-based Cognitive Assessment Tool (TabCAT)
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
2
Mobility - Grip Strength
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
3
Mobility - 10 Meter Gait Speed
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
4
Mobility - Clinical Test of Sensory Interaction on Balance (CTSIB)
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
5
Affect - Profile of Mood States Second Edition (POMS-2)
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
6
Affect - Ryff Scales of Psychological Wellbeing
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)