Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS

Launched by ZHIQI MAO · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a treatment called deep brain stimulation (DBS) affects thinking abilities, specifically executive function, in patients with Parkinson's disease (PD). The researchers want to understand if DBS helps or hinders cognitive function over time. Participants will undergo tests to measure their brain activity and thinking skills before the surgery, one month after, and then again at six and twelve months post-surgery. This study uses advanced technology to monitor brain signals while patients complete cognitive tests, which will help clarify how DBS impacts brain function and thinking skills in people with PD.

To be eligible for this trial, participants must be diagnosed with primary Parkinson's disease for at least five years, although there are some exceptions for those with shorter disease durations. They should have tried medication that improves their symptoms but are experiencing significant motor challenges despite treatment. The study is open to individuals under 75 years old who are willing to participate and can complete follow-up assessments. Importantly, people with severe cognitive issues or certain other health conditions will not be included in the study. Participants can expect to contribute to valuable research that aims to improve treatment strategies for those living with Parkinson's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with primary PD whose diagnosis meets "China's Diagnostic Criteria for Parkinson's Disease" issued in 2016.
• • 2. 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.
• • 3. Patients who have received levodopa medication with good efficacy and ≥30% improvement of symptoms in dopamine shock test.
• • 4. Significant decrease in the efficacy of drug therapy, intolerable motor complications, and drug side effects.
• • 5. 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.
• • 6. 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.
• • 7. Those who agree to undergo evaluation and can cooperate to complete the follow-up.
• • Exclusion Criteria：
• • 1. Have significant cognitive dysfunction.
• • 2. Have a psychiatric disorder such as severe depression, anxiety, or schizophrenia.
• • 3. Have underlying severe diseases that cannot tolerate surgery or affect post-operative survival.
• • 4. The disease has progressed to the terminal stage, and the patient is entirely unable to take care of himself/herself and is bedridden.
• • 5. Those with abnormal intracranial lesions and contraindications to MRI scanning, such as those with metal implants, claustrophobia, etc.
• • 6. Parkinson's disease syndrome and Parkinson's superimposed syndrome caused by other reasons.