Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's Disease

July 17, 2023 updated by: Guangrui Zhao, Tianjin Huanhu Hospital

Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's （A Retrospective Study）

As a surgical intervention, DBS can effectively relieve PD tremor, rigidity, bradykinesia and other symptoms. How to better screen patients suitable for DBS treatment and conduct reasonable preoperative and postoperative evaluation is crucial to judge the treatment effect and prognosis. The clinical symptom evaluation of PD patients can be divided into motor symptom evaluation and non-motor symptom evaluation. The motor symptoms of PD patients were evaluated by UPDRS III. The evaluation of non-motor symptoms in PD patients was mainly divided into three aspects: cognitive status, emotional status, and sleep status. Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) were used to assess the cognitive status of PD patients. The Hamilton Depression Scale (HAMD) was used to assess the patients' depression status. The Hamilton Anxiety Scale (HAMA) was used to assess the patients' anxiety status. The PD Sleep Scale 2nd version, The PD Sleep Scale 2nd version, PDSS - 2), and rem Sleep Behavior Disorder Questionnaire (sweet HK) (Rapid Eye Movement Sleep behaviors Disorder Questionnaire - Hong Kong, RBDQ - HK) to assess Sleep conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with primary Parkinson's disease were followed up for 1 year after deep brain stimulation, and the imaging data were intact

Description

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, age under 75, acute levodopa motor response ≥30%, and indication for STN-DBS. -

Exclusion Criteria: patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
improvement and no improvement
We observed whether the symptoms of patients improved after DBS surgery and divided them into groups.
Procedure: DBS
We observed the prognostic changes of patients after DBS surgery
imp+ and imp-
Procedure: DBS
We observed the prognostic changes of patients after DBS surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
motor symptom
Time Frame: 2023.1 to 2025.12
UPDRS III score changes
2023.1 to 2025.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Huanhu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinHH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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