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

Recruiting

• Conditions: Cognitive Impairment; Parkinson Disease
• Interventions: Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)

• Registration Number: NCT06090682
• Lead Sponsor: Tianjin Huanhu Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-10-14
• Last Update Submitted: 2023-10-14
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Study Start: 2023-11-01
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cognitive Impairment (CI) group and No Cognitive Impairment (NCI) group	Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)	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

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Rating Scale(MoCA)	December 2023 to December 2026	The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment
verbal fluency test (VF)	December 2023 to December 2026	VF test was used to assess frontal executive function and related language function

Secondary Outcome Measures

Name	Time	Method
the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III)	December 2023 to December 2026	Measures motor symptoms and Higher scores indicate more severe impairment in motor function

Trial Locations

Locations (1)

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China