RecruitingNot ApplicableNCT07022522

Impact of Frequency-specific Subthalamic Nucleus Subregion Stimulation on Inhibitory Control in Parkinson's Disease

Frequency-dependent Modulation of Inhibitory Control Via Subthalamic Nucleus Subregional Stimulation in Parkinson's Disease


Sponsor

Beijing Tiantan Hospital

Enrollment

20 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The core symptoms of Parkinson's disease (PD) include both motor and non-motor symptoms. Cognitive impairment is one of the most common non-motor symptoms in PD patients, with approximately 30% of patients exhibiting cognitive dysfunction at diagnosis and up to 80% eventually progressing to dementia. Among these, impairment of inhibitory control is the most detrimental cognitive dysfunction, as patients with compromised inhibitory control have difficulty suppressing impulsive behaviors and maintaining attention, which severely reduces their quality of life. The subthalamic nucleus (STN) plays an important role in the development and progression of PD. Along its longitudinal axis from posterior to anterior, it can be divided into three subregions: motor, associative, and limbic. The motor subregion receives extensive projections from the motor cortex and serves as a core node in the PD motor network, participating in the coordination and control of motor function. The associative subregion receives widespread projections from the prefrontal cortex and serves as a core node in the cognitive control network, regulating cognitive processes such as inhibitory control, set-shifting, and working memory. High-frequency (\>100Hz) deep brain stimulation of the STN (STN-DBS) is a well-established effective treatment for mid-to-late stage PD and can significantly improve motor symptoms. However, long-term high-frequency stimulation may exacerbate cognitive impairment. Recent studies have shown that low-frequency (4-10Hz) STN-DBS can improve cognitive functions such as working memory and verbal fluency in PD patients, but research on its effects in the domain of inhibitory control is lacking. Moreover, different STN subregions are involved in regulating distinct functions, yet previous studies have not differentiated the effects of stimulation targeting specific STN subregions. Therefore, conducting in-depth research on the effects of different stimulation frequencies applied to distinct STN subregions on inhibitory control function in PD patients is of great significance for exploring ways to improve cognitive impairment in PD and enhance the clinical individualized therapeutic effects of STN-DBS. This study plans to perform high- and low-frequency electrical stimulation of different STN subregions in PD patients who have undergone routine bilateral STN-DBS surgery, collect behavioral indicators during inhibitory control tasks (Arrow Flanker and Stop-Signal) under different stimulation conditions, and through comparative analysis, identify the specific stimulation sites and frequencies that can effectively improve inhibitory control function in PD patients.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing how different frequencies and locations of deep brain stimulation (DBS) in the subthalamic nucleus affect impulse control — the ability to stop or pause actions — in people with Parkinson's disease who already have a DBS device implanted. **You may be eligible if...** - You are between 40 and 80 years old - You have been diagnosed with idiopathic Parkinson's disease - You already have or are scheduled to receive a DBS device (indications for DBS surgery are met) **You may NOT be eligible if...** - You have significant complications from your DBS device (e.g., bleeding in the brain, swelling, or misplaced electrode) - You have significant dementia (MMSE score below threshold based on your education level) - You have a major psychiatric disorder - You have vision or hearing problems that would interfere with cognitive testing - You have other conditions that significantly affect thinking or memory Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE5Hz stimulation on the STN motor subregion

In this experimental arm, Parkinson's disease patients will undergo deep brain stimulation targeting the motor subregion of the subthalamic nucleus at a low frequency of 5Hz, with the primary objective of evaluating its specific effects on cognitive and behavioral outcomes such as inhibitory control and reaction time. The intervention involves precise postoperative programming of DBS electrodes localized to the motor subregion using neuroimaging verification.

DEVICE5Hz stimulation on the STN associative subregion

In this experimental arm, Parkinson's disease patients will undergo deep brain stimulation targeting the associative subregion of the subthalamic nucleus at a low frequency of 5Hz, with the primary objective of evaluating its specific effects on cognitive and behavioral outcomes such as inhibitory control and reaction time. The intervention involves precise postoperative programming of DBS electrodes localized to the associative subregion using neuroimaging verification.

DEVICE130Hz stimulation on the STN motor subregion

In this experimental arm, Parkinson's disease patients will undergo deep brain stimulation targeting the motor subregion of the subthalamic nucleus at a high frequency of 130Hz, with the primary objective of evaluating its specific effects on cognitive and behavioral outcomes such as inhibitory control and reaction time. The intervention involves precise postoperative programming of DBS electrodes localized to the motor subregion using neuroimaging verification.

DEVICE130Hz stimulation on the STN associative subregion

In this experimental arm, Parkinson's disease patients will undergo deep brain stimulation targeting the associative subregion of the subthalamic nucleus at a high frequency of 130Hz, with the primary objective of evaluating its specific effects on cognitive and behavioral outcomes such as inhibitory control and reaction time. The intervention involves precise postoperative programming of DBS electrodes localized to the associative subregion using neuroimaging verification.

DEVICENo stimulation

In this control arm, Parkinson's disease patients will not receive active deep brain stimulation, with the DBS system maintained in an "off" state throughout the testing period.


Locations(1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT07022522


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