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NCT Number: NCT06090682

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

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.

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300070, China

Location status: Recruiting

Location contact

Yin Shaoya, doctor

CONTACT

[email protected]

+86 18622139285

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Montreal Cognitive Rating Scale(MoCA)

    Time frame: December 2023 to December 2026

    The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment

  2. verbal fluency test (VF)

    Time frame: December 2023 to December 2026

    VF test was used to assess frontal executive function and related language function

Secondary outcomes

  1. the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III)

    Time frame: December 2023 to December 2026

    Measures motor symptoms and Higher scores indicate more severe impairment in motor function

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Keke, doctor

CONTACT

[email protected]

+86 18920195507

Zhao Guangrui, doctor

CONTACT

[email protected]

+86 18956405513

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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