Status:
UNKNOWN
Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS
Lead Sponsor:
Zhiqi Mao
Conditions:
Parkinson's Disease
Executive Function
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
In recent years, deep brain stimulation (DBS) has become the primary treatment for patients with medically uncontrolled Parkinson's disease (PD). Nevertheless, previous studies have shown that it has ...
Detailed Description
In recent years, deep brain electrical stimulation (DBS) has become a primary treatment for improving clinical symptoms in Parkinson's disease (PD) patients with predominantly motor slowing after poor...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with primary PD whose diagnosis meets "China's Diagnostic Criteria for Parkinson's Disease" issued in 2016.
- Disease duration: In principle, PD patients with disease duration ≥5 years, patients with disease duration \<5 years but meeting the clinical confirmation criteria for primary PD, with confirmation of surgical indications, the duration of the disease can be relaxed to 4 years, PD patients with predominantly tremor, with unsatisfactory improvement of tremor by standardized drug therapy and severe tremor affecting the patient's quality of life, the duration of the disease can be relaxed to 3 years after evaluation.
- Patients who have received levodopa medication with good efficacy and ≥30% improvement of symptoms in dopamine shock test.
- Significant decrease in the efficacy of drug therapy, intolerable motor complications, and drug side effects.
- Disease severity: In patients with symptomatic fluctuation of the "on-off" phenomenon, the Hoehn-Yahr stage of the off phase is 2.5-4.0.
- Age: The age of patients undergoing surgery is usually \<75 years old, and if the patient's physical condition is good, the age limit can be appropriately relaxed.
- Those who agree to undergo evaluation and can cooperate to complete the follow-up.
- Exclusion Criteria：
- Have significant cognitive dysfunction.
- Have a psychiatric disorder such as severe depression, anxiety, or schizophrenia.
- Have underlying severe diseases that cannot tolerate surgery or affect post-operative survival.
- The disease has progressed to the terminal stage, and the patient is entirely unable to take care of himself/herself and is bedridden.
- Those with abnormal intracranial lesions and contraindications to MRI scanning, such as those with metal implants, claustrophobia, etc.
- Parkinson's disease syndrome and Parkinson's superimposed syndrome caused by other reasons.
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06175897
Start Date
October 1 2023
End Date
July 1 2025
Last Update
December 19 2023
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, China