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NCT Number: NCT07519798

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

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) Score

    Time frame: Baseline and immediately after intervention

  2. Change in Gait-Related and Balance-Related Dual-Task Cost

    Time frame: Baseline and immediately after intervention

  3. Change in Working Memory Performance

    Time frame: Baseline and immediately after intervention

Secondary outcomes

  1. Change in Brain function

    Time frame: Baseline and immediately after intervention

  2. Chang in Brain structure

    Time frame: Baseline and immediately after intervention

Sponsors and collaborators

Lead sponsor

Shanghai University of Sport

Other

Collaborators

  • Huashan Hospital

Registry information

Official study title

The Effects of Transcranial Temporal Interferential Electrical Stimulation on Cognitive Function, Dual-Task Performance and Neuroplasticity in Individuals With Mild Cognitive Impairment

Acronym: TIS-MCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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