Testing deep brain stimulation's effect on memory in Parkinson's disease
Tests whether brain stimulation of the substantia nigra affects memory in people with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Mechanism and Application of DBS in the Treatment of PD
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 70 years old?
Source: NCT06400017, who can take part
Where in China
- Beijing Tiantan HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT06400017
- Record updated
- 31 May 2025
- Original description
Project name: The mechanism and application of deep brain stimulation in the treatment of Parkinson's diseaseRead full original descriptionShow less
Mechanism and Application of Deep Brain Stimulation in the Treatment of Parkinson's Disease
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.
Inclusion: 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: There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3 times normal); 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 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.