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

• Sponsor: Tianjin Huanhu Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05959161
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 41

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Deep Brain Stimulation; Non-motor Symptoms	Procedure: DBS

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's （A Retrospective Study）
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. motor symptom [2023.1 to 2025.12]

   UPDRS III score changes

Eligibility Criteria

Criteria

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

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 -

Contacts and Locations

Locations

No locations specified.

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 of Neurosurgery, Huanhu Hospital, Tianjin University, Tianjin Huanhu Hospital
• ClinicalTrials.gov Identifier: NCT05959161
• Other Study ID Numbers: TianjinHH
• First Posted: Jul 25, 2023
• Last Update Posted: Jul 25, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Jul 25, 2023