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

NCT06175897 | Unknown

• 1 other identifier: ChinaPLAGH-ZH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Parkinson's Disease; Executive Function; Electroencephalogram; Functional Near - Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Change in EEG-fNIRS performance

  To explore the differences in cognitive brain network changes in PD patients by using EEG-fNIRS photofusion technology. The EEG-fNIRS bimodal brain network of PD patients were constructed, and the network characteristic indexes, such as node degree, characteristic path length, and clustering coefficient, were counted. The cognitive differences of PD patients were interpreted by the actual physiological state represented by the brain network feature indicators, for example, a high node entry degree means high information inflow in the brain area where the node is located, short feature path length means high efficiency of whole-brain information transfer in the patient, and large clustering coefficient means high degree of modularity in the brain area of the PD patient. These characteristic indexes can better reflect PD patients' cognitive state and change differences.

  up to 1 month (DBS-on) ,6 months，12 months

Secondary Outcomes (6)

• Change in Stroop scores

  up to 1 month (DBS-on), 6 months, 12 months

• Change in Trail Making Test A and B scores

  up to 1 month (DBS-on), 6 months, 12 months

• Change in Mini-mental State Examination scores

  up to 1 month (DBS-on), 6 months, 12 months

• Change in Neuropsychiatric Inventory (NPI) scores

  up to 1 month (DBS-on), 6 months, 12 months

• Change in Activities of Daily Living scores

  up to 1 month (DBS-on), 6 months, 12 months

Study Arms (2)

surgical group

EXPERIMENTAL

Undergoing DBS

Procedure: Deep Brain Stimulation

control group

SHAM COMPARATOR

Undergoing non-DBS

Procedure: non-Deep Brain Stimulation

Interventions

Deep Brain Stimulation PROCEDURE

An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 0.5mm) will be inserted into the dorsolateral part of bilateral STN nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously. Device: STN-DBS devices DBS electrode: 3389 (Medtronic, Minneapolis, MN, USA) or L301 (PINS Medical, Beijing, China) or 1200 (SceneRay, Suzhou, China); Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).

surgical group

non-Deep Brain Stimulation PROCEDURE

Patients with PD were given their original drug dose and did not receive DBS.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhiqi Mao: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Zhiqi Mao, PhD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhiqi Mao, PhD

CONTACT

8618910155994; markmaoqi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 19, 2023
• Study Start: October 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: July 1, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CN (1)