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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05959161
Other study ID # TianjinHH
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2026

Study information

Verified date July 2023
Source Tianjin Huanhu Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2026
Est. primary completion date September 1, 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 75 Years
Eligibility 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 Design


Intervention

Procedure:
DBS
We observed the prognostic changes of patients after DBS surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Huanhu Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary motor symptom UPDRS III score changes 2023.1 to 2025.12
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