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

Not Applicable

Not yet recruiting

• Conditions: AD-MCI
• Interventions: Device: Transcranial electrical stimulation

• Registration Number: NCT06470074
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Start: 2024-09
• Primary Completion: 2026-01
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Male or female AD-MCI patients between the ages of 50-85; The psychological evaluation was in accordance with MMSE score of 18-30 (including 18 and 30) and CDR score of 0.5.

Can cooperate to complete clinical research.

Exclusion Criteria

There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active stimulus group	Transcranial electrical stimulation	Patients were assigned into active stimulus group according to random number table
sham stimulus control group	Transcranial electrical stimulation	Patients were assigned into sham stimulus control group according to random number table

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale	1-12 weeks	Evaluate the improvement of clinical symptoms

Secondary Outcome Measures

Name	Time	Method
resting EEG	1-12 weeks	EEG power in multiple band
head MRI	1-12 weeks	Changes of brain function by fMRI

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University.; 🇨🇳 Beijing, Beijing, China