Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease

NCT07543094 | Enrolling By Invitation DMC

• 1 other identifier: 2025-621
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy and safety of a novel non-invasive brain stimulation technique-Temporal Interference Stimulation (TIS)-in patients with early-stage Alzheimer's disease. A total of 40 participants will be randomly assigned to either the TIS group or the sham stimulation group. The intervention will last for 2 weeks, with cognitive and safety assessments at baseline, post-treatment, and 12 weeks after treatment.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Temporal Interference Stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) Score

  The ADAS-Cog 11 is a rater-administered scale designed to assess the severity of cognitive dysfunction in Alzheimer's disease. The total score ranges from 0 to 70, with a lower score indicating better cognitive performance. The change from baseline to the end of treatment will be analyzed.

  Baseline, End of treatment (2 weeks)

Secondary Outcomes (9)

• Change in Mini-Mental State Examination (MMSE) Score

  Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)

• Change in Montreal Cognitive Assessment (MoCA) Score

  Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)

• Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

  Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)

• Change in Shape Trails Test (STT) - Part A Time

  Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)

• Change in Shape Trails Test (STT) - Part B Time

  Baseline, End of treatment (2 weeks), Post-treatment follow-up (12 weeks)

Study Arms (2)

Temporal Interference Stimulation

EXPERIMENTAL

Device: Temporal Interference Stimulation

Sham Temporal Interference Stimulation

SHAM COMPARATOR

Device: Sham Stimulation

Interventions

Temporal Interference Stimulation DEVICE

Device: The non-invasive brain stimulator NervioX is used to administer Temporal Interference Stimulation (TIS). Stimulation Parameters: Frequencies: 2000 Hz and 2005 Hz (resulting in a 5 Hz theta rhythm envelope). Stimulation Intensity: 1.0-2.0 mA (peak current). Stimulation Target: Bilateral hippocampus Session Duration: 40 minutes per session. Treatment Course: 5 sessions per week, for 2 consecutive weeks, totaling 10 sessions.

Temporal Interference Stimulation

Sham Stimulation DEVICE

Device: The same NervioX device is used. Stimulation Parameters: The device is programmed to deliver a real stimulation (1.0-2.0 mA) for the initial 30 seconds of the session to mimic the initial sensation experienced by the active group. Subsequently, the current is automatically reduced to 0 mA for the remainder of the 40-minute session. The device screen continues to display the stimulation as ongoing to maintain the blinding. The session frequency and total course (5 sessions/week for 2 weeks, 10 sessions total) are identical to the active intervention group.

Sham Temporal Interference Stimulation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the 2024 NIA-AA Revised Criteria , defined as positivity for at least one Core 1 biomarker:
• Positive plasma p-tau217 test (positivity defined by clinically validated diagnostic cutoffs provided by the assay manufacturer); or
• Positive amyloid PET scan; or
• Abnormal cerebrospinal fluid (CSF) ratios, including p-tau181/Aβ42, t-tau/Aβ42, or Aβ42/40.
• \*Reference: Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169.\*
• Age between 50 and 75 years, inclusive.
• Minimum of 6 years of formal education.
• Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.
• MMSE≥21.
• Stable dosage of cognitive-enhancing medications (e.g., cholinesterase inhibitors and/or memantine) for at least 6 weeks prior to screening.

You may not qualify if:

• Current or past history of significant neurological disorders other than AD (e.g., epilepsy, stroke, multiple sclerosis), intracranial lesions, neurosurgery, or significant head trauma.
• Current use of medications that may substantially impair cognitive function (e.g., anticonvulsants, antipsychotics, benzodiazepines).
• Any contraindication for MRI or the stimulation device (e.g., metallic implants, pacemakers, severe claustrophobia).
• Significant structural brain abnormalities on MRI (e.g., hydrocephalus, stroke, or severe white matter lesions \[Fazekas score ≥ 3\]).
• Diagnosis of major depression or other active, uncontrolled psychiatric disorders.
• Any severe or unstable medical condition that, in the investigator's judgment, could compromise participant safety or study validity (e.g., cardiovascular, renal, hepatic, respiratory, active cancer), or a history of alcohol/substance dependence.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 2000025, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Doctoral Supervisor

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-10

Locations

CN (1)