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

Sponsor
Tianjin Huanhu Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06090682
Collaborator
(none)
200
1
48
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect and Mechanism of Deep Brain Stimulation and Transcranial Magnetic Stimulation on Parkinson's Disease With Cognitive Impairment
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

Arm Intervention/Treatment
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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Huanhu Hospital Tianjin Tianjin China 300070

Sponsors and Collaborators

  • Tianjin Huanhu Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangrui Zhao, Associate Professor, Tianjin Huanhu Hospital
ClinicalTrials.gov Identifier:
NCT06090682
Other Study ID Numbers:
  • TianjinHH-02
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guangrui Zhao, Associate Professor, Tianjin Huanhu Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2023