Clinical Exploratory Research of Medial Prefrontal Cortex Combined With Dorsolateral Prefrontal Cortex Electrical Stimulation in the Treatment of Alzheimer's Disease

NCT05971030 | Unknown DMC

• 1 other identifier: 2023062
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD) is a common neurodegenerative disease characterized by progressive cognitive impairment and memory impairment, and is also a major cause of global dementia, characterized by progressive decline in memory and daily living behavior. The incidence rate of AD increases with age. The prevalence rate of AD among men over 65 years old in China is 3.4%, and that of women is 7.7%, with a total prevalence rate of 5.9%. Among them, people over 65 years old can live for an average of 4 to 8 years after being diagnosed with Alzheimer's disease. According to statistics, there were approximately 5.98 million AD patients in China in 2005, reaching 10.2 million in 2020 and 22.5 million by 2040, making it the largest country with AD. At present, the treatment of AD is mostly limited to drug therapy, including Acetylcholine enzyme inhibitor, N-methyl-D-aspartate receptor antagonist and brain cell metabolism promoter. Although there are many types of drugs, their efficacy is not satisfactory, as they not only cannot effectively prevent and cure AD, but also cannot slow down the progression of AD. Regarding the surgical treatment of AD, neuromodulatory surgery, especially DBS (Deep Brain Electrical Stimulation), involves implanting stimulation electrodes into deep neural nuclei in the brain and performing electrical stimulation to change the excitability of the corresponding nuclei or neural circuits, and has been included in alternative treatment plans. In the past 20 years, DBS technology has been continuously explored for the treatment of AD, but an increasing number of clinical trials have shown that there is no effective target for AD-DBS. Therefore, there is an urgent need for new treatment methods to improve the current treatment status.

Conditions

Alzheimer Disease; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (1)

• Auditory verbal learning test (AVLT) before and after DBS

  ALVT will be performed before and after DBS operations to examine the AD. patients' ability.

  1 months before DBS, 1 month, 2 months, 3 months, 6 months, and 12 months after DBS.

Secondary Outcomes (2)

• Mini-mental State Examination (MMSE) before and after DBS

  1 months before DBS, 1 month, 2 months, 3 months, 6 months, and 12 months after DBS.

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  1 months before DBS, 1 month, 2 months, 3 months, 6 months, and 12 months after DBS.

Study Arms (1)

CBS for mPFC and dlPFC

EXPERIMENTAL

Case series of AD patients who accept CBS for mPFC and dlPFC

Device: Cortical brain stimulation of mPFC and dlPFC

Interventions

Cortical brain stimulation of mPFC and dlPFC DEVICE

Left medial prefrontal cortex combined with dorsolateral prefrontal cortex electrical stimulation

CBS for mPFC and dlPFC

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 40 to 70;
• eets the diagnostic criteria for mild to moderate AD;
• A CDR score of 0.5 or 1.0;
• The MMSE score is between 18 and 28;
• Regularly taking cholinesterase inhibitors for more than 6 months

You may not qualify if:

• Existence of brain structural abnormalities (such as brain tumors, cerebral infarction, and intracranial hematoma);
• Suffering from other neurological or psychiatric diseases;
• Accompanying comorbidities that are not suitable for surgical treatment;
• Individuals with contraindications for MRI or PET testing

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yuqing Zhang

CONTACT

83198930; yuqzhang@vip.163.com

Yan Yin

CONTACT

83198930

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case series

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 2, 2023
• Study Start: July 30, 2023
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after the study finished

Locations

CN (1)