Parkinson's DiseaseNCT06175897
Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS
A study testing Deep Brain Stimulation and non-Deep Brain Stimulation in people with Parkinson's Disease and Executive Function, run by Zhiqi Mao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease, Executive Function, Electroencephalogram
- What is being tested?
- Deep Brain Stimulation and non-Deep Brain Stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Zhiqi Mao, PhD, markmaoqi@163.com
About this study
Official title: 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
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.
Read the detailed description
In recent years, deep brain electrical stimulation (DBS) has become a primary treatment for improving clinical symptoms in Parkinson's disease (PD) patients with predominantly motor slowing after poor drug effects from conventional drug therapy medications or after the progression of the disease. However, previous studies have been controversial in examining whether DBS-STN promotes or impairs cognitive function in patients with PD. Previous studies have found that DBS may affect executive function in patients with PD and that specific brain regions are closely related to executive function. In this study, the investigators used electroencephalograph-functional near-infrared spectroscopy (EEG-fNIRS) to obtain brain network connectivity in subjects and to explore the possible relationship between executive function and brain network connectivity in patients with Parkinson's disease. To explore the possible brain network connectivity affecting execution in DBS-STN and to predict postoperative executive function in PD patients in DBS.
Among the single cognitive domains impaired, executive function impairment is the most common, accounting for more than 70% of the cases, and impairment of attention, working memory, and visuospatial ability are also more common. Impaired executive function is the most characteristic cognitive impairment in PD patients, which is related to the disruption of the integrity of the frontal-striatal loops, designing a wide range of functional brain regions, such as the frontal lobe, parietal lobe, cingulate gyrus, thalamus, substantia nigra, and so on, and clinically manifested as impaired cognitive flexibility, planning, concept formation, working memory, and learning ability. Executive dysfunction can seriously affect patients' social behavior, especially when performing more complex tasks that require the integration of multiple steps in a particular order.
Previous studies have found that brain network connectivity in specific brain regions is closely related to cognitive function, for example, there have been many clinical studies based on functional MRI blood oxygenation signals, but because of the poor immunity to electromagnetic interference, patients with implanted electrodes have to be DBS-off in order to do the MRI. Because of poor anti-motor interference, only some motor imagery and simple finger movements can be acquired under the DBS-off condition for functional MRI, and functional MRI has been an important issue limiting cognitive neuroscience research due to its low temporal resolution and its inability to monitor in real-time the changes of cortical brain blood oxygenation signals in the task paradigm.
Therefore, this study plans to design a multicenter, prospective, randomized, parallel-controlled equipotent clinical trial, which innovatively combines electroencephalography (EEG) with high temporal resolution and functional near-infrared spectroscopy (fNIRS) with a high spatial resolution to monitor cortical oxygenation signals in real-time, so that the brain electrophysiological and blood oxygenation signals can be acquired in real-time during a test of executive function (Stroop/TMT). The real-time measurement and evaluation of cognitive function by synchronously acquiring electrophysiological and oxygenation signaling changes in the brain while the patient is performing the executive function test (Stroop/TMT) and obtaining real-time EEG-fNIRS brain network data during the executive function test has always been a higher-order field of cognitive function research. The present study investigated the mechanisms of executive function impairment in PD patients and whether DBS-STN affects the brain network mechanisms of executive function. It is hoped to (1) quantify cognitive function and possible trends in cognitive functioning in PD patients by EEG-fNIRS technique, (2) Explain whether there are differences in executive function at the level of brain functional network connectivity between surgical and conservative treatments and whether there are interaction effects of the differences with the duration of treatment and the treatment modality as well as to analyze their simple effects, (3) To minimize artificial confounders of short-term learning effects and testers familiar with 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.
In this study, the investigators planned to design a multicenter, prospective, randomized, parallel-controlled clinical trial. A total of 80 patients were randomly assigned to the DBS-STN group. The DBS treatment group, with the non-DBS treatment group, routinely DBS-on at 1 month postoperatively. The conservative treatment routinely on oral medication and the data on patients' brain function was collected by the simultaneous EEG-fNIRS bimodal technique in combination with cognitive testing (Stroop/TMT) at baseline, 1 month after DBS (DBS-on), and at 6 months/12 months after DBS, respectively.
- Conditions
- Parkinson's Disease, Executive Function, Electroencephalogram, Functional Near - Infrared Spectroscopy
- Being tested
- Deep Brain Stimulation, non-Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationProcedure or surgery
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).
non-Deep Brain StimulationProcedure or surgery
Patients with PD were given their original drug dose and did not receive DBS.
| Study group | Role | What they receive |
|---|---|---|
| surgical group | Experimental | Undergoing DBS Receives: Procedure: Deep Brain Stimulation |
| control group | Sham comparator | Undergoing non-DBS Receives: Procedure: non-Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 month (DBS-on) ,6 months，12 months
Secondary outcomes (6)
Change in Stroop scores
Stroop A, B, and C elapsed time per card, number of correct (timing accurate to 0.01 s).
The metrics reflecting the amount of interference (Stroop interference effect, SIE) include:
SIE elapsed time = card C elapsed time - card B elapsed time; SIE correct number = card B correct number - card C correct number. The larger the SIE is, the lower the interference suppression effect is, and the more serious the impairment of executive function is.
The indexes observed in this study include the number of correct and elapsed times of cards A, B, and C, the number of elapsed time and correct number of SIE, the elapsed time of cards (C-A-B), the rate of increase of elapsed time (C-B)/A, the rate of decrease of correct number (B-C)/A, and the elapsed time/correct number of each card.
Measured: up to 1 month (DBS-on), 6 months, 12 months
Change in Trail Making Test A and B scores
TMT-A, and TMT-B recording indicators include: TMT-A elapsed time number (timing accurate to 0.01s); TMT-B elapsed time number (timing accurate to 0.01s); Number of TMT-A and TMT-B error connection reminders, number of pen lifts; Interference Error Coefficient (IE): (TMT-A - TMT-B) / TMT-A
Measured: up to 1 month (DBS-on), 6 months, 12 months
Change in Mini-mental State Examination scores
Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and a higher value represents a better outcome.
Measured: up to 1 month (DBS-on), 6 months, 12 months
Change in Neuropsychiatric Inventory (NPI) scores
The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome.
Measured: up to 1 month (DBS-on), 6 months, 12 months
Change in Activities of Daily Living scores
Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.
Measured: up to 1 month (DBS-on), 6 months, 12 months
Change in Montreal Cognitive Assessment scores
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 1 month (DBS-on), 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Oct 2023
- Primary completion31 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiqi Mao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiqi Mao, Chinese PLA General Hospital
- Investigators
- Zhiqi Mao, PhD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175897
- Sponsor's protocol ID
- ChinaPLAGH-ZH
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06175897
- Acronym / sponsor ID
- ChinaPLAGH-ZH
- Conditions
- Parkinson's Disease, Executive Function, Electroencephalogram, Functional Near - Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhiqi MaoUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Dec 2023 (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.
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.
Detailed description
In recent years, deep brain electrical stimulation (DBS) has become a primary treatment for improving clinical symptoms in Parkinson's disease (PD) patients with predominantly motor slowing after poor drug effects from conventional drug therapy medications or after the progression of the disease. However, previous studies have been controversial in examining whether DBS-STN promotes or impairs cognitive function in patients with PD. Previous studies have found that DBS may affect executive function in patients with PD and that specific brain regions are closely related to executive function. In this study, the investigators used electroencephalograph-functional near-infrared spectroscopy (EEG-fNIRS) to obtain brain network connectivity in subjects and to explore the possible relationship between executive function and brain network connectivity in patients with Parkinson's disease. To explore the possible brain network connectivity affecting execution in DBS-STN and to predict postoperative executive function in PD patients in DBS.
Among the single cognitive domains impaired, executive function impairment is the most common, accounting for more than 70% of the cases, and impairment of attention, working memory, and visuospatial ability are also more common. Impaired executive function is the most characteristic cognitive impairment in PD patients, which is related to the disruption of the integrity of the frontal-striatal loops, designing a wide range of functional brain regions, such as the frontal lobe, parietal lobe, cingulate gyrus, thalamus, substantia nigra, and so on, and clinically manifested as impaired cognitive flexibility, planning, concept formation, working memory, and learning ability. Executive dysfunction can seriously affect patients' social behavior, especially when performing more complex tasks that require the integration of multiple steps in a particular order.
Previous studies have found that brain network connectivity in specific brain regions is closely related to cognitive function, for example, there have been many clinical studies based on functional MRI blood oxygenation signals, but because of the poor immunity to electromagnetic interference, patients with implanted electrodes have to be DBS-off in order to do the MRI. Because of poor anti-motor interference, only some motor imagery and simple finger movements can be acquired under the DBS-off condition for functional MRI, and functional MRI has been an important issue limiting cognitive neuroscience research due to its low temporal resolution and its inability to monitor in real-time the changes of cortical brain blood oxygenation signals in the task paradigm.
Therefore, this study plans to design a multicenter, prospective, randomized, parallel-controlled equipotent clinical trial, which innovatively combines electroencephalography (EEG) with high temporal resolution and functional near-infrared spectroscopy (fNIRS) with a high spatial resolution to monitor cortical oxygenation signals in real-time, so that the brain electrophysiological and blood oxygenation signals can be acquired in real-time during a test of executive function (Stroop/TMT). The real-time measurement and evaluation of cognitive function by synchronously acquiring electrophysiological and oxygenation signaling changes in the brain while the patient is performing the executive function test (Stroop/TMT) and obtaining real-time EEG-fNIRS brain network data during the executive function test has always been a higher-order field of cognitive function research. The present study investigated the mechanisms of executive function impairment in PD patients and whether DBS-STN affects the brain network mechanisms of executive function. It is hoped to (1) quantify cognitive function and possible trends in cognitive functioning in PD patients by EEG-fNIRS technique, (2) Explain whether there are differences in executive function at the level of brain functional network connectivity between surgical and conservative treatments and whether there are interaction effects of the differences with the duration of treatment and the treatment modality as well as to analyze their simple effects, (3) To minimize artificial confounders of short-term learning effects and testers familiar with 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.
In this study, the investigators planned to design a multicenter, prospective, randomized, parallel-controlled clinical trial. A total of 80 patients were randomly assigned to the DBS-STN group. The DBS treatment group, with the non-DBS treatment group, routinely DBS-on at 1 month postoperatively. The conservative treatment routinely on oral medication and the data on patients' brain function was collected by the simultaneous EEG-fNIRS bimodal technique in combination with cognitive testing (Stroop/TMT) at baseline, 1 month after DBS (DBS-on), and at 6 months/12 months after DBS, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical group | Experimental | Procedure: Deep Brain StimulationUndergoing DBS |
| control group | Sham comparator | Procedure: non-Deep Brain StimulationUndergoing non-DBS |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Deep Brain StimulationAn 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). | Procedure or surgery | surgical group |
| non-Deep Brain StimulationPatients with PD were given their original drug dose and did not receive DBS. | Procedure or surgery | control group |
Primary outcome
Change in EEG-fNIRS performance
Time frame: up to 1 month (DBS-on) ,6 months，12 months
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.
6 secondary outcomes
Change in Stroop scores
Time frame: up to 1 month (DBS-on), 6 months, 12 months
Change in Trail Making Test A and B scores
Time frame: up to 1 month (DBS-on), 6 months, 12 months
Change in Mini-mental State Examination scores
Time frame: up to 1 month (DBS-on), 6 months, 12 months
Change in Neuropsychiatric Inventory (NPI) scores
Time frame: up to 1 month (DBS-on), 6 months, 12 months
Change in Activities of Daily Living scores
Time frame: up to 1 month (DBS-on), 6 months, 12 months
Change in Montreal Cognitive Assessment scores
Time frame: up to 1 month (DBS-on), 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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. This study is not recruiting at the moment.
Zhiqi Mao, PhD study director
Chinese PLA General 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 Deep Brain Stimulation and non-Deep Brain Stimulation in people with Parkinson's Disease and Executive Function, run by Zhiqi Mao 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiqi Mao, PhD (8618910155994, markmaoqi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG-fNIRS performance (time frame: up to 1 month (DBS-on) ,6 months，12 months). 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 19 Dec 2023.