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

NCT06470074 | Not Yet Recruiting DMC

• 1 other identifier: [2022]110-1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

AD-MCI

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Scale

  Evaluate the improvement of clinical symptoms

  1-12 weeks

Secondary Outcomes (2)

• resting EEG

  1-12 weeks

• head MRI

  1-12 weeks

Study Arms (2)

active stimulus group

ACTIVE COMPARATOR

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

Device: Transcranial electrical stimulation

sham stimulus control group

SHAM COMPARATOR

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

Device: Transcranial electrical stimulation

Interventions

Transcranial electrical stimulation DEVICE

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

active stimulus group; sham stimulus control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Penghu Wei, doctor

CONTACT

18601986863; weipenghu@xwhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)