Effects of Transcranial Temporal Interference Stimulation on Cognitive Function in Mild Cognitive Impairment

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.

Interventions

• Active Temporal Interference Stimulation (TIS) · DEVICE

  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.

• Placebo / Sham TIS · DEVICE

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Shanghai University of Sport, Shanghai, Shanghai Municipality, China