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Effect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment

T

Tianjin Huanhu Hospital

Status

Enrolling

Conditions

Cognitive Impairment
Parkinson Disease

Treatments

Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)

Study type

Observational

Funder types

Other

Identifiers

NCT06090682
TianjinHH-02

Details and patient eligibility

About

This study intends to apply structural and functional brain network neuroimaging techniques combined with image post-processing methods to explore the differences in brain network changes in PD patients with cognitive impairment after DBS or TMS.

Full description

A variety of post-processing methods (VBM, SPM, CAT, LEAD-DBS, etc.) were used to analyze structural brain network images (sMRI, DTI) and functional brain network images (rs-fMRI, PET) based on connectomics, and combined with the changes of clinical symptoms before and after treatment. To study the mechanism of the influence of neural regulation on brain network, and further analyze how DBS and TMS improve the cognitive symptoms of PD patients from the perspective of brain connectomics, so as to explore the occurrence and development of Parkinson's disease with cognitive impairment and the possible improvement mechanism.According to the individual differences in clinical symptoms of different PD patients, better stimulation sites and the best brain network are sought to further guide the surgical plan, so as to obtain the best clinical treatment effect.

Enrollment

200 estimated patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, acute levodopa motor response ≥30%, and indication for STN-DBS.

Exclusion criteria

Exclusion criteria included patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery.

Trial design

200 participants in 1 patient group

Cognitive Impairment (CI) group and No Cognitive Impairment (NCI) group
Description:
We intend to recruit 200 patients with primary PD to undergo DBS surgery or only TMS treatment according to whether the surgical indication is available. We will observe the changes in cognitive function of patients before and after different brain stimulation treatments. Parkinson's disease patients with cognitive impairment after brain stimulation were divided into cognitive impairment group, and those without cognitive impairment after treatment were divided into no cognitive impairment group
Treatment:
Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)

Trial contacts and locations

1

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Central trial contact

Feng Keke, doctor; Zhao Guangrui, doctor

Data sourced from clinicaltrials.gov

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