Mild Cognitive Impairment (MCI)
Conditions
Brief summary
To explore the effects of transcranial temporal interference stimulation (tTIS) on cognitive function and dual-task walking performance, as well as its underlying neuroimaging mechanisms, in individuals with mild cognitive impairment.
Detailed description
This is a randomized, double-blind, sham-controlled, crossover trial. Participants aged 60-80 years with mild cognitive impairment (MoCA \< 26, CDR = 0.5) will receive a single 20-minute session of individualized 5 Hz transcranial temporal interference stimulation (tTIS) targeting the left hippocampus (2 mA, 2000/2005 Hz carriers) and a sham session in random order, with a 7-day washout period. The primary outcomes are change in MoCA score, dual-task gait/balance cost, and working memory performance. Secondary outcomes include change in brain function and brain structure. The study aims to enroll 40 participants. Safety and tolerability will be assessed via structured questionnaires.
Interventions
Active tTIS delivered via surface electrodes targeting the hippocampus. Parameters: 2 mA baseline-to-peak intensity, 20-minute duration with 30-second ramp-up and ramp-down. The stimulation protocol is individualized based on each participant's T1-weighted structural MRI using finite element modeling to optimize electric field distribution to the hippocampal target.
DEVICEPlacebo / Sham TIS
Sham stimulation delivered using the same electrode placement and parameters as active stimulation. To mimic the sensory experience without effective neuromodulation, active current is delivered only during the 30-second ramp-up and ramp-down periods. During the 20-minute stimulation period, no current is delivered. Participants are unable to distinguish sham from active stimulation based on sensation.
Sponsors
Shanghai University of Sport
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 60-80 years * Community-dwelling * Montreal Cognitive Assessment (MoCA) score \< 26 * Clinical Dementia Rating (CDR) score = 0.5 * Activities of Daily Living (ADL) score \< 26 (largely intact daily function) * Does not meet criteria for dementia diagnosis (based on DSM-5 or NIA-AA criteria) * No contraindications for MRI examination (no metallic implants, no claustrophobia) * Able to provide written informed consent
Exclusion criteria
* Neurological conditions that may cause cognitive decline (e.g., cerebrovascular disease, encephalitis, Parkinson's disease, Huntington's disease) * Severe visual, auditory, or language impairments preventing completion of neuropsychological assessments * Severe depression (Geriatric Depression Scale \> 10) or other major psychiatric disorders * History of seizures or epilepsy * Previous deep brain stimulation or electroconvulsive therapy within 6 months * Alcohol or substance dependence * Concurrent participation in another interventional clinical trial * Contraindications for non-invasive brain stimulation: electronic or ferromagnetic implants, non-MRI compatible metal implants, history of seizures, pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Montreal Cognitive Assessment (MoCA) Score | Baseline and immediately after intervention |
| Change in Gait-Related and Balance-Related Dual-Task Cost | Baseline and immediately after intervention |
| Change in Working Memory Performance | Baseline and immediately after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Change in Brain function | Baseline and immediately after intervention |
| Chang in Brain structure | Baseline and immediately after intervention |
Countries
China
Outcome results
None listed