Mechanism and Application of DBS in the Treatment of PD
Recruiting
N/AInterventional Study
Parkinson's Disease and Parkinsonism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Beijing Tiantan Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 50-70 with Parkinson's disease. Participants will undergo a procedure involving brain stimulation to study its effects on memory and cognitive function.
Are You a Good Fit for This Trial?
You may be able to join if
I want to participate in this study and can provide consent.
I am between 50 and 70 years old.
I have a clinical diagnosis of typical Parkinson's disease.
I have had Parkinson's disease for less than 20 years.
I plan to have deep brain stimulation surgery to manage my symptoms.
I do not have any major structural issues found in my MRI.
My vision and hearing are mostly normal.
I can follow the tasks required in the study.
You may not be able to join if
I have serious mental, cognitive, or psychological disorders.
I have conditions that make neurosurgery unsafe, like hydrocephalus or significant heart disease.
I have serious health issues, like tumors or severe liver or kidney problems.
I have issues in my brain or nervous system that prevent MRI scans.
I scored less than 24 on the Mini-Mental State Examination.
I scored less than 18 on the Montreal Cognitive Assessment.
I have claustrophobia.
I have any implants that could affect MRI safety.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Project name: The mechanism and application of deep brain stimulation in the treatment of Parkinson's disease
Objective:
To test the hypothesis that electrical stimulation of substantia nigra regulates cognitive dysfunction in Parkinson's disease and to reveal its electrophysiological mechanism.
Study design:
This study is a self-controlled prospective cohort study. By comparing the behavioral…
Project name: The mechanism and application of deep brain stimulation in the treatment of Parkinson's disease
Objective:
To test the hypothesis that electrical stimulation of substantia nigra regulates cognitive dysfunction in Parkinson's disease and to reveal its electrophysiological mechanism.
Study design:
This study is a self-controlled prospective cohort study. By comparing the behavioral characteristics of the memory paradigm under microelectrode stimulation during DBS operation and the characteristics of the underlying electrophysiological signals, and the behavioral characteristics of the memory paradigm and the characteristics of brain network activity under electrical stimulation when DBS is turned on 1 month after surgery. The regulatory effect of substantia nigra DBS on memory network was analyzed.
Cases: 60
Case selection:
Inclusion criteria:
1)Voluntarily participate in the clinical study and sign the informed consent; 2) Age 50-70 years old, gender unlimited; 3) The clinical diagnosis is consistent with typical PD, and the medical history is less than 20 years; 4) Patients who intend to use 3.0T magnetic resonance compatible dual-channel DBS device (G106R or G106RS, Beijing Pinchi Company) for bilateral subthalamic nucleus DBS surgery to control PD symptoms; 5) MRI excluded patients with obvious structural changes; 6) The visual acuity and hearing of the subjects were basically normal, and the compliance was good, and they could complete the tasks listed in the experimental scheme in accordance with the standards.
Exclusion criteria:
1)Serious mental, cognitive and psychological disorders, unable to sign informed consent or cooperate with the operation and various tasks; 2) There are contraindications for neurosurgery, such as hydrocephalus, cerebral atrophy, cerebrovascular sequelae, heart disease and other cardiovascular and cerebrovascular diseases; 3) There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3 times normal); 4) There is intracranial space occupation, cerebrovascular disease, mental illness, other neurological diseases, claustrophobia, or there is an implant in the body, which affects the nuclear magnetic scan; 5) The results of the Mini-Mental State Scale (MMSE) \<24 or the Montreal Cognitive Assessment Scale (MoCA) \<18 in the preoperative assessment, or the results of other scales indicate the presence of severe dementia.
therapeutic schedule: This study did not change the patient's overall treatment regimen, and only electrical stimulation was tested during and after DBS surgery
Efficacy evaluation:
Effectiveness evaluation index (primary efficacy index and secondary efficacy index) : accuracy of memory paradigm, response speed Safety evaluation indicators: blood pressure, heart rate, dual frequency index, patient complaints and symptoms
Statistical methods:
The group t test was used to compare the normal distribution between the measurement data groups. For measurement data with non-normal distribution, Wilcoxon rank sum test was used for comparison between groups.
The study period is January 1, 2024 - December 31, 2026.
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Eligibility Criteria
Inclusion Criteria:
* Voluntarily participate in the clinical study and sign the informed consent;
* Age 50-70 years old, gender unlimited;
* The clinical diagnosis is consistent with typical PD, and the medical history is less than 20 years;
* Patients who intend to use 3.0T magnetic resonance com…
Inclusion Criteria:
* Voluntarily participate in the clinical study and sign the informed consent;
* Age 50-70 years old, gender unlimited;
* The clinical diagnosis is consistent with typical PD, and the medical history is less than 20 years;
* Patients who intend to use 3.0T magnetic resonance compatible dual-channel DBS device (G106R or G106RS, Beijing Pinchi Company) for bilateral subthalamic nucleus DBS surgery to control PD symptoms;
* MRI excluded patients with obvious structural changes;
* The visual acuity and hearing of the subjects were basically normal, and the compliance was good, and they could complete the tasks listed in the experimental scheme in accordance with the standards.
Exclusion Criteria:
* Serious mental, cognitive and psychological disorders, unable to sign informed consent or cooperate with the operation and various tasks;
* There are contraindications for neurosurgery, such as hydrocephalus, cerebral atrophy, cerebrovascular sequelae, heart disease and other cardiovascular and cerebrovascular diseases;
* There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3 times normal);
* There is intracranial space occupation, cerebrovascular disease, mental illness, other neurological diseases, claustrophobia, or there is an implant in the body, which affects the nuclear magnetic scan;
* The results of the Mini-Mental State Scale (MMSE) \<24 or the Montreal Cognitive Assessment Scale (MoCA) \<18 in the preoperative assessment, or the results of other scales indicate the presence of severe dementia.
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