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

NCT ID: NCT06090682

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Impairment (CI) group and No Cognitive Impairment (NCI) group

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

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tianjin Huanhu Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Guangrui Zhao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhao Guangrui, doctor

Role: CONTACT

+86 18956405513

Feng Keke, doctor

Role: CONTACT

+86 18920195507

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yin Shaoya, doctor

Role: primary

+86 18622139285

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TianjinHH-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tDCS on Parkinson's Disease Cognition
NCT03025334 RECRUITING NA
Internet-CBT for Parkinsons Disease
NCT02627885 COMPLETED NA