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

NCT07519798 | Enrolling By Invitation DMC

• 2 other identifiers: 102772025RT208ChiCTR2600119709
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Brain function

  Baseline and immediately after intervention

• Chang in Brain structure

  Baseline and immediately after intervention

Study Arms (2)

Active TIS followed by Placebo TIS

EXPERIMENTAL

Participants first receive single-session active TIS targeting the hippocampus for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS.

Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS

Placebo TIS followed by Active TIS

EXPERIMENTAL

Participants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the hippocampus.

Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS

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.

Active TIS followed by Placebo TIS; Placebo TIS followed by Active TIS

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.

Active TIS followed by Placebo TIS; Placebo TIS followed by Active TIS

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Sport: lead
• Huashan Hospital: collaborator

Study Sites (1)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 9, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication of the main results.
• Access Criteria: Data will be made available upon reasonable request to the corresponding author. Data will be shared with researchers who submit a methodologically sound research proposal and intend to use the data for non-commercial purposes. Applicants must sign a data access agreement.

Locations

CN (1)