High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With Subject… (NCT07395609) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With Subjective Cognitive Decline
United States60 participantsStarted 2026-05-15
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 older adults with Subjective Cognitive Decline (SCD), relative to an SCD control group receiving white noise sensory stimulation. 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 range65 Years – 89 Years
SexALL
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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) norms8
* 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 Scale32
* In line with recommendations of the SCD task force33 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 Questionnaire32 (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…
What they're measuring
1
Cognition
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
2
Grip strength
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
3
10m Gait Speed
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
4
Clinical Test of Sensory Interaction on Balance (CTSIB)
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)
5
Affect - 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)
7
Affect - Satisfaction with Life Scale
Timeframe: Baseline, halfway through (1.5 months), and post-intervention (3 months)