Investigating the effects of deep brain stimulation on cognition in Parkinson's disease patients

Effects of STN Deep Brain Stimulation on Cognition and Brain Networks in Parkinson's Disease Patients Analyzed Based on EEG and Functional Near-infrared Spectroscopy

This study is testing whether deep brain stimulation can improve or worsen thinking skills in people with Parkinson's disease who aren't getting enough relief from their medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06175897 on ClinicalTrials.gov

What this trial studies

This study aims to explore the impact of deep brain stimulation (DBS) of the subthalamic nucleus (STN) on cognitive function, specifically executive function, in patients with Parkinson's disease (PD). Using electroencephalography and functional near-infrared spectroscopy (EEG-fNIRS), researchers will assess brain network connectivity and its relationship with cognitive performance at various postoperative intervals. The study will include patients diagnosed with PD who have experienced inadequate symptom control from medication. The goal is to clarify whether DBS-STN enhances or impairs cognitive abilities over time.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with primary Parkinson's disease who have had the condition for at least 5 years and have not achieved satisfactory symptom control with medication.

Not a fit: Patients with early-stage Parkinson's disease or those whose cognitive function is not significantly impaired may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive outcomes for Parkinson's disease patients undergoing deep brain stimulation.

How similar studies have performed: Previous studies have shown mixed results regarding the cognitive effects of DBS in Parkinson's disease, indicating that this area of research is still evolving.

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.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Zhiqi Mao, PhD

Conditions: Parkinson's Disease, Executive Function, Electroencephalogram, Functional Near - Infrared Spectroscopy