NCT06470074

Clinical Multicenter Randomized Controlled Study of Non-invasive Brain Oscillation Modulation in the Treatment of AD-MCI Patients

Xuanwu Hospital, Capital Medical University

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (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 transcranial electrical stimulation in the treatment of AD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.

Detailed description

This project plans to recruit 124 patients with AD-MCI. They were randomly divided into transcranial electrical active stimulation group and sham stimulation group. Patients receive treatment 3-7 days a week, and the daily treatment time is 20-60 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

• AD-MCI

Interventions

Type	Name	Description
DEVICE	Transcranial electrical stimulation	Transcranial electrical stimulation can modulate the brain functional network through weak transcranial current

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