Parkinson's Disease (Patients with Parkinson's Disease requiring deep brain stimulation)
Conditions
Interventions
Group1:The subject first receives conventional high-frequency stimulation of the subthalamic nucleus (STN) with no effective stimulation or sham stimulation applied to the substantia nigra pars reticu
Group2:The subject first receives high-frequency stimulation of the subthalamic nucleus (STN) combined with low-frequency stimulation of the substantia nigra pars reticulata (SNr) for one month. After
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years (inclusive), gender unrestricted. 2. Patients diagnosed with clinically established Parkinson’s disease or clinically probable Parkinson’s disease according to the MDS diagnostic criteria for Parkinson’s disease. 3. Patients meeting the surgical indications for DBS as outlined in the *Chinese Expert Consensus on Deep Brain Stimulation Therapy for Parkinson’s Disease (Second Edition)* and scheduled to undergo DBS surgery. 4. Presence of poorly controlled gait disorders despite dopaminergic therapy, with a score of =2 on item 2.13 (Freezing of Gait) of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II under optimized clinical treatment conditions. 5. The participant and their family members, after being fully informed and understanding the study objectives, procedures, expected treatments, and risks, agree to undergo treatment with an implantable neurostimulation system and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe cognitive impairment (Mini-Mental State Examination (MMSE) score: illiterate <17, primary school education <20, junior high school education or above <24). 2. Comorbid severe (refractory) depression, anxiety, schizophrenia, or other psychiatric disorders. 3. Severe comorbidities involving other organ systems, such as confirmed malignant tumors, severe cardiac, hepatic, or renal diseases, severe hypertension, severe diabetes, or diabetes with cardiovascular and cerebrovascular complications. 4. Contraindications to surgery (e.g., history of cochlear implants, cardiac pacemakers, implantable cardioverter defibrillators, stereotactic neuroablative surgery, previous implantation of unilateral or bilateral similar devices, etc.), or having undergone other surgeries within the past six months that are deemed by the investigator to potentially affect the study, or other neurosurgical contraindications. 5. Pregnant or breastfeeding women, or women of childbearing potential who are unable to take effective contraceptive measures. 6. Participants currently enrolled in other clinical trials, or having participated in a clinical trial within the past three months (excluding registry studies). 7. Individuals deemed by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction in the New Freezing of Gait Questionnaire (NFOG-Q) score relative to the preoperative baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| NFOG-Q Score Reduction Value (After Crossover Completion);MDS-UPDRS Axial Symptoms Score Reduction Value;MDS-UPDRS Part III (Motor Section) Score Reduction Value;Berg Balance Scale Score Reduction Value;Parkinson's Disease Questionnaire (PDQ-39) Score Reduction Value;Hamilton Depression Rating Scale (HAMD) Score Reduction Value;Hamilton Anxiety Rating Scale (HAMA) Score Reduction Value;Daily Levodopa Equivalent Dose (LEDD) Reduction;Quantitative gait analysis findings;Local field potential frequency band characteristics at the implantation target site; | — |
Countries
China
Contacts
Public ContactLi Jian Yu
Xuanwu Hospital, Capital Medical University
Outcome results
None listed