Effect and Safety of Non-invasive Electrical Stimulation in Alzheimer's Disease

NCT07694921 | Enrolling By Invitation

• 1 other identifier: IIT20250215C-R2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD) is the most common neurodegenerative disorder, characterized primarily by cognitive impairment as its main clinical symptom, often accompanied by emotional disturbances such as depression and anxiety, imposing a significant disease burden. Temporal Interference Stimulation (TIS) is an emerging non-invasive electrical stimulation technique that precisely targets deep structures within the hippocampus through interference of multiple electric fields. This study will administer a two-week TIS treatment to patients with AD co-occurring depression, targeting the hippocampus, and compare changes in patients' cognitive function, scores on depression and anxiety scales, and functional magnetic resonance imaging (fMRI) data before and after treatment. An emotional word recall task will be administered during fMRI scans. The aim of this study is to investigate the efficacy, safety, and neural mechanisms of TIS-mediated modulation of hippocampal circuits in improving cognitive and emotional functioning in patients with AD and comorbid depression.

Conditions

Alzheimer's Disease(AD)

Outcome Measures

Primary Outcomes (2)

• Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog)

  The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) is a brief, standardized, and widely used neuropsychological assessment designed to measure the severity of cognitive impairment, specifically the core symptoms of Alzheimer's disease (AD).Total Score Range:0 to 80. The higher scores mean a worse outcome.

  From enrollment to the end of treatment at 2 weeks

• The 24-item Hamilton Depression Scale (HAMD-24)

  The 24-item Hamilton Depression Scale (HAMD-24) is one of the most widely used clinician-administered questionnaires in psychiatry to assess the severity of depression.The total score ranges from 0 to 76, and higher scores mean a worse outcome.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (3)

• Mini-Mental State Examination (MMSE)

  From enrollment to the end of treatment at 2 weeks

• Clinical Dementia Rating (CDR)

  From enrollment to the end of treatment at 2 weeks

• Hamilton anxiety scale (HAMA)

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

Temporal Interference Stimulation

EXPERIMENTAL

Specific electrode sites are customized for the subject through magnetic resonance scanning, the Hippocampal region to be stimulated is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment.

Device: Temporal Interference Stimulation

Interventions

Temporal Interference Stimulation DEVICE

During the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is Individualized.

Temporal Interference Stimulation

Eligibility Criteria

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

You may qualify if:

• (1) Right-handed, Han ethnicity; (2) Meet the clinical diagnostic criteria for Alzheimer's disease as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Age ≥60 years, with at least primary school education, and capable of cooperating during testing; (4) Mini-Mental State Examination (MMSE) score \<24; (5) Clinical Dementia Rating (CDR) score of 0.5 or 1; (6) The 24-item Hamilton Depression Scale (HAMD-24) score ≥20.

You may not qualify if:

• (1) Systemic diseases causing cognitive impairment, such as hypothyroidism, vitamin B12 or folic acid deficiency, and acquired immunodeficiency syndrome; (2) Comorbid neurological disorders including epilepsy, Parkinson's disease, normal-pressure hydrocephalus, and brain tumors; (3) Comorbid mental illnesses such as schizophrenia, bipolar disorder, or psychiatric disorders due to alcohol or drug abuse; (4) History of post-traumatic loss of consciousness, intracranial infection, or cerebrovascular disease; (5) A Hachinski Ischemic Scale (HIS) score ≥4; (6) Cranial MRI revealing ischemic lesions involving critical brain regions like the hippocampus, thalamus, basal ganglia, or angular gyrus, or multiple ischemic lesions in deep gray matter of the cerebral hemispheres; (7) Inability to undergo MRI due to special conditions such as internal metal implants or pacemakers.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)