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

NCT05959161 | Not Yet Recruiting DMC

• 1 other identifier: TianjinHH
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Deep Brain Stimulation; Non-motor Symptoms

Outcome Measures

Primary Outcomes (1)

• motor symptom

  UPDRS III score changes

  2023.1 to 2025.12

Study Arms (2)

improvement and no improvement

We observed whether the symptoms of patients improved after DBS surgery and divided them into groups.

Procedure: DBS

imp+ and imp-

Procedure: DBS

Interventions

DBS PROCEDURE

We observed the prognostic changes of patients after DBS surgery

imp+ and imp-; improvement and no improvement

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery, Huanhu Hospital, Tianjin University

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2023

Record last verified: 2023-07