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

Parkinson Disease Clinical Trial

Official title:

Effect and Mechanism of Deep Brain Stimulation and Transcranial Magnetic Stimulation on Parkinson's Disease With Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090682
• Other study ID #: TianjinHH-02
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: October 2023
• Source: Tianjin Huanhu Hospital
• Contact: Zhao Guangrui, doctor
• Phone: +86 18956405513
• Email: Guangrui-Zhao[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Parkinson Disease

Intervention

Device:
• Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)
We observed the changes in cognitive function of patients before and after different brain stimulation treatments, and further compared the effects of different brain stimulation treatments on cognitive function of PD patients and the related mechanisms according to whether DBS surgery was performed or TMS therapy was given only according to the surgical indications.

Locations

Country	Name	City	State
China	Tianjin Huanhu Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Huanhu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Rating Scale(MoCA)	The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment	December 2023 to December 2026
Primary	verbal fluency test (VF)	VF test was used to assess frontal executive function and related language function	December 2023 to December 2026
Secondary	the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III)	Measures motor symptoms and Higher scores indicate more severe impairment in motor function	December 2023 to December 2026