Parkinson DiseaseNCT07022522
Impact of Frequency-specific Subthalamic Nucleus Subregion Stimulation on Inhibitory Control in Parkinson's Disease
A study testing 5Hz stimulation on the STN motor subregion, 5Hz stimulation on the STN associative subregion and 130Hz stimulation on the STN motor subregion in people with Parkinson Disease and Deep Brain Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation
- What is being tested?
- 5Hz stimulation on the STN motor subregion, 5Hz stimulation on the STN associative subregion and 130Hz stimulation on the STN motor subregion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years old;
- Diagnosed with idiopathic Parkinson's disease;
- Meeting the indications for DBS surgery.
Who cannot join
- Patient declined to participate in the study;
- Presence of significant post-DBS complications (e.g., intracranial hemorrhage, cerebral edema, electrode misplacement);
- Significant psychiatric disorders or dementia (MMSE score <20 for uneducated; <23 for 1-6 years education; <27 for ≥7 years education);
- Visual or auditory impairment affecting cognitive task performance
- History of conditions potentially impairing cognitive function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Jianguo Zhang, +86 13601294613, zjguo73@126.com
About this study
Official title: Frequency-dependent Modulation of Inhibitory Control Via Subthalamic Nucleus Subregional Stimulation in Parkinson's Disease
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.
Read more
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.
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Being tested
- 5Hz stimulation on the STN motor subregion, 5Hz stimulation on the STN associative subregion, 130Hz stimulation on the STN motor subregion, 130Hz stimulation on the STN associative subregion, No stimulation
- Keywords
- Deep Brain Stimulation, Cognition, Subthalamic Nucleus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5Hz stimulation on the STN motor subregionDevice
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.
5Hz stimulation on the STN associative subregionDevice
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.
130Hz stimulation on the STN motor subregionDevice
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.
130Hz stimulation on the STN associative subregionDevice
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.
No stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| No stimulation | Sham comparator | Not described Receives: Device: No stimulation |
| 5Hz stimulation on the STN motor subregion | Experimental | 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. Receives: Device: 5Hz stimulation on the STN motor subregion |
| 5Hz stimulation on the STN associative subregion | Experimental | 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. Receives: Device: 5Hz stimulation on the STN associative subregion |
| 130Hz stimulation on the STN motor subregion | Experimental | 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. Receives: Device: 130Hz stimulation on the STN motor subregion |
| 130Hz stimulation on the STN associative subregion | Experimental | 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. Receives: Device: 130Hz stimulation on the STN associative subregion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral paradigm results
- Arrow Flanker Task : Reaction time for congruent and incongruent trials.
Measured: Outcome measures were assessed starting at 5 minutes after each stimulation condition
Secondary outcomes (2)
Behavioral paradigm results
Stop-Signal Task: Stop-signal reaction time (SSRT).
Measured: Outcome measures were assessed starting at 5 minutes after each stimulation condition
Motor score
MDS-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.
Measured: Outcome measures were assessed starting at 5 minutes after each stimulation condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Oct 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Zhang, Beijing Tiantan Hospital
- Investigators
- Jianguo Zhang, M.D., Ph.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022522
- Sponsor's protocol ID
- KY2024-163-02
- Status last verified
- Mar 2025
- First submitted
- 29 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency-dependent Modulation of Inhibitory Control Via Subthalamic Nucleus Subregional Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07022522
- Acronym / sponsor ID
- KY2024-163-02
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Cognition, Subthalamic Nucleus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No stimulation | Sham comparator | Device: No stimulation |
| 5Hz stimulation on the STN motor subregion | Experimental | Device: 5Hz stimulation on the STN motor subregionIn 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. |
| 5Hz stimulation on the STN associative subregion | Experimental | Device: 5Hz stimulation on the STN associative subregionIn 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. |
| 130Hz stimulation on the STN motor subregion | Experimental | Device: 130Hz stimulation on the STN motor subregionIn 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. |
| 130Hz stimulation on the STN associative subregion | Experimental | Device: 130Hz stimulation on the STN associative subregionIn 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-80 years old;
- Diagnosed with idiopathic Parkinson's disease;
- Meeting the indications for DBS surgery.
Key exclusion criteria (5 listed)
- Patient declined to participate in the study;
- Presence of significant post-DBS complications (e.g., intracranial hemorrhage, cerebral edema, electrode misplacement);
- Significant psychiatric disorders or dementia (MMSE score <20 for uneducated; <23 for 1-6 years education; <27 for ≥7 years education);
- Visual or auditory impairment affecting cognitive task performance
- History of conditions potentially impairing cognitive function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5Hz stimulation on the STN motor subregionIn 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. | Device | 5Hz stimulation on the STN motor subregion |
| 5Hz stimulation on the STN associative subregionIn 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. | Device | 5Hz stimulation on the STN associative subregion |
| 130Hz stimulation on the STN motor subregionIn 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. | Device | 130Hz stimulation on the STN motor subregion |
| 130Hz stimulation on the STN associative subregionIn 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. | Device | 130Hz stimulation on the STN associative subregion |
| No stimulationIn 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. | Device | No stimulation |
Primary outcome
Behavioral paradigm results
Time frame: Outcome measures were assessed starting at 5 minutes after each stimulation condition
1. Arrow Flanker Task : Reaction time for congruent and incongruent trials.
2 secondary outcomes
Behavioral paradigm results
Time frame: Outcome measures were assessed starting at 5 minutes after each stimulation condition
Motor score
Time frame: Outcome measures were assessed starting at 5 minutes after each stimulation condition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianguo Zhang, M.D., Ph.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5Hz stimulation on the STN motor subregion, 5Hz stimulation on the STN associative subregion and 130Hz stimulation on the STN motor subregion in people with Parkinson Disease and Deep Brain Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hutao Xie (+8618756921517, xieht0123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral paradigm results (time frame: Outcome measures were assessed starting at 5 minutes after each stimulation condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.