Development of a Novel Multidimensional Therapeutic Intervention Protocol for MCI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorYuan Shen
About this trial
As populations age, Alzheimer's disease (AD) is increasing while disease-modifying drugs remain elusive, making early diagnosis and intervention essential. Building on advances in neuromodulation and virtual reality (VR), we target amnestic mild cognitive impairment (aMCI)-the prodromal stage of AD-as a key window for prevention. Preliminary evidence shows disrupted theta-delta phase-amplitude coupling in prefrontal and temporal cortices in aMCI, whereas olfactory enrichment can enhance hippocampal synaptic function, improve cognition, and potentially lower AD risk. We will conduct a large-scale clinical cohort study to test the neural mechanisms and clinical efficacy of multi-site, cross-frequency transcranial alternating current stimulation (tACS) combined with multisensory (visual-olfactory-auditory) VR. A comprehensive database spanning demographic, neuropsychological, biochemical, neuroimaging, and neuromodulation parameters will guide optimal protocols and provide objective evidence for non-pharmacological interventions, informing development of a microcurrent brain stimulator and a portable VR device.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Olfactory stimulation
BehavioralOlfactory stimulation were set as follows: Essential oil types: yuzu, lavender, lemon, and mint. Concentration: 158 μL of essential oil + 50 mL of water. The mixed solution was poured into the test tubes of the olfactory instrument, ensuring that the liquid levels of the four solutions were kept at the same height. Each scent was released for 30 seconds, followed by a 10-second air interval, with each cycle lasting 20 minutes.
Temporal Interference,TI
Biological/VaccineDuring stimulation, the parameters were set as follows: Δf=40Hz (2000Hz vs. 2040Hz) 2mA Stimulation duration: 20min We fixed the stimulation protocol and used a standard head to simulate stimulation of the entorhinal region.
Olfactory-TI Stimulation
Combination productDuring stimulation, the parameters were set as follows: Δf=40Hz (2000Hz vs. 2040Hz) 2mA Stimulation duration: 20min We fixed the stimulation protocol and used a standard head to simulate stimulation of the entorhinal region. Olfactory stimulation were set as follows: Essential oil types: yuzu, lavender, lemon, and mint. Concentration: 158 μL of essential oil + 50 mL of water. The mixed solution was poured into the test tubes of the olfactory instrument, ensuring that the liquid levels of the four solutions were kept at the same height. Each scent was released for 30 seconds, followed by a 10-second air interval, with each cycle lasting 20 minutes.
Sham Control
Combination productDuring stimulation, the parameters were set as follows: Δf=0Hz (2000Hz vs. 2000Hz) 2mA Stimulation duration: 20min. Olfactory stimulation were set as follows: Essential oil types: air. lasting 20 minutes.
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: Olfactory Stimulation GroupExperimental treatment 1 intervention
Group B: TI Stimulation GroupExperimental treatment 1 intervention
Group C: Olfactory-TI Stimulation GroupExperimental treatment 1 intervention
Group D: Sham Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Olfactory Sensitivity (TDI score)
Change in olfactory function measured with the Sniffin' Sticks Threshold-Discrimination-Identification (TDI) composite score. Unit of Measure: TDI score, 1-48 (higher scores indicate better olfactory function).
Time frame
Baseline; 30 minutes after Session 1; 30 minutes after Session 5; 30 minutes after Session 10; 1 week after Session 10.2
Path Integration - Angle Deviation
Absolute angular error during the path-integration task. Lower values indicate better performance. Unit of Measure: Degrees (°); lower is better.
Time frame
Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.3
Path Integration - Distance Deviation
Difference between actual and ideal path length during the path-integration task. Lower values indicate better performance. Unit of Measure: Meters (m); lower is better.
Time frame
Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.4
Path Integration - Composite Accuracy (M_ROC_AUC)
Area under the ROC curve computed from multivariate PI features to quantify task accuracy/reliability across sessions. Unit Measure: AUC, 0.00-1.00 (higher values indicate better accuracy/stability).
Time frame
Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.Secondary outcomes
1
Activities of Daily Living (ADL - Barthel Index)
Change in functional ability using the Barthel Index. Unit of Measure: Barthel Index, 0-100 (higher scores indicate greater independence).
Time frame
Baseline; 30 minutes after Session 1; 30 minutes after Session 5; 30 minutes after Session 10; 1 week after Session 10.2
Adverse Events Related to Intervention
Incidence of device- or procedure-related adverse events (e.g., skin irritation, headache, dizziness, nausea). Unit of Measure: Number of participants with ≥1 adverse event (count).
Time frame
Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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