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

Capital Medical University

Status: Not yet enrolling

Conditions: VaD-MCI

Treatments: Device: simultaneous cognitive training with transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06470113

[2022]110-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

The inclusion criteria based on MRI examination include: ① Multiple supratentorial subcortical lacunae (3-20 mm) with or without white matter degeneration, or moderate and severe white matter degeneration (Fazekas score ≥2) with or without lacunae; ② White matter lesions such as cortical/watershed infarction, cerebral hemorrhage, hydrocephalus or other causes (such as multiple sclerosis) were excluded; ③ There was no medial atrophy of hippocampus or temporal lobe (MTA 0); Can cooperate to complete clinical research.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups

simultaneous cognitive training with active transcranial magnetic stimulation group

Active Comparator group

Description:

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

Treatment:

Device: simultaneous cognitive training with transcranial magnetic stimulation

simultaneous cognitive training with sham transcranial magnetic stimulation group

Sham Comparator group

Description:

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

Treatment:

Device: simultaneous cognitive training with transcranial magnetic stimulation