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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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

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AD-MCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly assigned to the active stimulation group and sham stimulation group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patients were randomly assigned to the active stimulation group and sham stimulation group, Patients，Care Provider and Outcomes Assessor did not know the patient grouping.

Study Groups

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active stimulus group

Patients were assigned into active stimulus group according to random number table

Group Type ACTIVE_COMPARATOR

Transcranial electrical stimulation

Intervention Type DEVICE

Transcranial electrical stimulation can modulate the brain functional network through weak transcranial current

sham stimulus control group

Patients were assigned into sham stimulus control group according to random number table

Group Type SHAM_COMPARATOR

Transcranial electrical stimulation

Intervention Type DEVICE

Transcranial electrical stimulation can modulate the brain functional network through weak transcranial current

Interventions

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Transcranial electrical stimulation

Transcranial electrical stimulation can modulate the brain functional network through weak transcranial current

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No