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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 been controversial whether DBS-subthal amic nucleus (STN) has facilitated or impaired cognitive function in patients with PD. The etiology of the effect of DBS on the single cognitive domain, executive function, has yet to be clarified. Previous clinical studies in which DBS was performed in patients with PD have been performed under the Stroop effect. TMT (Trail Making Test A and B) cognitive tests and simultaneous acquisition of brain function data by electroencephalograph-functional near-infrared spectroscopy (EEG-fNIRS) have yet to be reported. To investigate the effect of DBS-STN on executive function in PD patients and whether there are differences at baseline, 1-month postoperative (DBS-on), 6 months postoperative follow-up, and 12 months postoperative follow-up. Under the condition of electroencephalograph-functional near-infrared spectroscopy (EEG-fNIRS) bimodal technology fusion, The investigators allow PD patients to operate the test of executive function (Stroop/TMT), real-time monitoring of cranial neurophysiology-oxygenation signals, and explore the changes of the brain function network of PD patients, and hope to achieve the following objectives through objective and scientific-technological means: (1) quantify the cognitive function of PD patients through EEG-fNIRS technology and possible trends of changes; (2) explain whether executive functions differ at the level of brain functional network connectivity between surgical and conservative treatments and whether the differences have interaction effects with treatment duration and treatment modalities, as well as analyze their simple effects; (3) To minimize artificial confounders of short-term learning effects and testers common to previous neurocognitive psychobehavioral tests; (4) To explore the mechanism of DBS on the changes of cortical brain networks in PD patients, to avoid or reduce the interference of surgery on cognitive functions, and to provide a theoretical basis for treating personalized surgical plans.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhiqi Mao, PhD
markmaoqi@163.com
8618910155994
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 80
Treatments
Experimental: surgical group
Undergoing DBS
Sham_comparator: control group
Undergoing non-DBS
Sponsors
Leads: Zhiqi Mao

This content was sourced from clinicaltrials.gov

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