Clinical Multicenter Randomized Controlled Study of Simultaneous Cognitive Training With Transcranial Magnetic Stimulation in the Treatment of VaD-MCI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of simultaneous cognitive training with transcranial magnetic stimulation in the treatment of VaD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of tACS Combined With CCT for Patients With MCI

NCT04135742

Mild Cognitive Impairment

UNKNOWN NA

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease

NCT04599764

Transcranial Direct Current Stimulation Functional Magnetic Resonance Imaging Early Alzheimer's Disease

RECRUITING NA

Computerized Cognitive Training for MCI

NCT03232047

Mild Cognitive Impairment

UNKNOWN NA

Improvement of Memory in Mild Cognitive Impairment

NCT05708001

Mild Cognitive Impairment

RECRUITING NA

Cognitive Training Combined With Transcranial Direct Current Stimulation in Older Adults in a Home-based Context

NCT04817124

Aging

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This project plans to recruit 164 patients with VaD-MCI. They were randomly divided into simultaneous cognitive training with active transcranial magnetic stimulation group and simultaneous cognitive training with sham transcranial magnetic stimulation group. Patients receive treatment 3-7 days a week, and the daily treatment time is 20-40 minutes. The duration of treatment is 1-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination were completed. Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination at the follow-up 6 months after the treatment. Fill in the treatment side effect scale and adverse event form. Keep the original oral drug dosage unchanged during the treatment process.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

VaD-MCI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly assigned to the active stimulation group and sham stimulation group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patients were randomly assigned to the active stimulation group and sham stimulation group, Patients，Care Provider and Outcomes Assessor did not know the patient grouping.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

simultaneous cognitive training with active transcranial magnetic stimulation group

Patients were assigned into simultaneous cognitive training with active transcranial magnetic stimulation group according to random number table

Group Type ACTIVE_COMPARATOR

simultaneous cognitive training with transcranial magnetic stimulation

Intervention Type DEVICE

simultaneous cognitive training with transcranial magnetic stimulation can enhance the therapeutic effect and improve brain function non-invasively.

simultaneous cognitive training with sham transcranial magnetic stimulation group

Patients were assigned into simultaneous cognitive training with sham transcranial magnetic stimulation group according to random number table

Group Type SHAM_COMPARATOR

simultaneous cognitive training with transcranial magnetic stimulation

Intervention Type DEVICE

simultaneous cognitive training with transcranial magnetic stimulation can enhance the therapeutic effect and improve brain function non-invasively.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

simultaneous cognitive training with transcranial magnetic stimulation

simultaneous cognitive training with transcranial magnetic stimulation can enhance the therapeutic effect and improve brain function non-invasively.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Male or female VaD-MCI patients between the ages of 50-85; The psychological evaluation was in accordance with MMSE score of 18-26 (including 18 and 26) and CDR score of 0.5.

Exclusion Criteria

Suffering from any cause of disturbance of consciousness. Severe aphasia or physical disability can not complete the neuropsychological examination Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.

Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).

Have a history of using antipsychotics for more than five years before diagnosis.

There are contraindications for head MRI examination.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No