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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07022522
Enrollment
20
Registered
2025-06-15
Start date
2024-10-01
Completion date
2026-12-31
Last updated
2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Deep Brain Stimulation

Keywords

Deep Brain Stimulation, Cognition, Subthalamic Nucleus

Brief 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.

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.

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.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age 40-80 years old; 2. Diagnosed with idiopathic Parkinson's disease; 3. Meeting the indications for DBS surgery.

Exclusion criteria

1. Patient declined to participate in the study; 2. Presence of significant post-DBS complications (e.g., intracranial hemorrhage, cerebral edema, electrode misplacement); 3. Significant psychiatric disorders or dementia (MMSE score \<20 for uneducated; \<23 for 1-6 years education; \<27 for ≥7 years education); 4. Visual or auditory impairment affecting cognitive task performance 5. History of conditions potentially impairing cognitive function.

Design outcomes

Primary

MeasureTime frameDescription
Behavioral paradigm resultsOutcome measures were assessed starting at 5 minutes after each stimulation condition1\. Arrow Flanker Task : Reaction time for congruent and incongruent trials.

Secondary

MeasureTime frameDescription
Behavioral paradigm resultsOutcome measures were assessed starting at 5 minutes after each stimulation conditionStop-Signal Task: Stop-signal reaction time (SSRT).
Motor scoreOutcome measures were assessed starting at 5 minutes after each stimulation conditionMDS-UPDRS III score: The Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) is a standardized clinical assessment tool for evaluating motor symptoms in Parkinson's disease (PD). The total score ranges from 0 to 132, with higher scores indicating more severe motor dysfunction, including increased rigidity, bradykinesia (slowed movement), tremor, and postural instability. Conversely, lower scores reflect milder or absent motor impairments, suggesting better motor function and symptom control.

Countries

China

Contacts

Primary ContactHutao Xie
xieht0123@163.com+8618756921517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026