NCT06470113

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• VaD-MCI

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-01-01
• Completion: 2026-11-01
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: China