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

Xuanwu Hospital, Capital Medical University

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.

Study Overview

• Status: Not yet recruiting
• Conditions: VaD-MCI
• Intervention / Treatment: Device: simultaneous cognitive training with transcranial magnetic stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Penghu Wei, doctor; Phone Number: 18601986863; Email: weipenghu@xwhosp.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University.
      • Contact: Peng-Hu Wei, doctor; Phone Number: +86-18601986863; Email: weipenghu@xwhosp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: 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.
Sham Comparator: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression Scale	Evaluate the improvement of clinical symptoms	1-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resting EEG	EEG power in multiple band	1-12 weeks
head MRI	Changes of brain function by fMRI	1-12 weeks

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: [2022]110-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No