An observational study in Parkinson Disease and Cognitive Impairment, sponsored by Tianjin Huanhu Hospital. Recruiting at 1 site in China. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Tianjin Huanhu Hospital · Observational
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 200 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Tianjin Huanhu Hospital is the lead sponsor of 25 studies on the registry; 19 are open to participants now.
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Recruiting 200 patients with primary Parkinson's disease, aged less than 75 years old, regardless of gender, without prior brain injury, and with a history of brain surgery
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.
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
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.
Montreal Cognitive Rating Scale(MoCA)
The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment
Time frame: December 2023 to December 2026
verbal fluency test (VF)
VF test was used to assess frontal executive function and related language function
Time frame: December 2023 to December 2026
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
Time frame: December 2023 to December 2026
Plan to share: No — We observed the therapeutic effects of DBS and TMS on cognitive impairment in patients with Parkinson's disease and analyzed the possible mechanisms of cognitive changes
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Tianjin Huanhu Hospital