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New treatment option for Parkinson's Disease and Parkinsonism
Official title Mechanism and Application of DBS in the Treatment of PD
ClinicalTrials.gov ID: NCT06400017
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- 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...
- MRI excluded patients with obvious structural changes;
You likely can't join if
- 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...
- There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3...
- There is intracranial space occupation, cerebrovascular disease, mental illness, other neurological diseases, claustrophobia, or there is an implant...
- The results of the Mini-Mental State Scale (MMSE) \<24 or the Montreal Cognitive Assessment Scale (MoCA) \<18 in the preoperative assessment, or the...
See the full eligibility 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 people were basically normal, and the compliance was good, and they could complete the tasks listed in the experimental scheme in accordance with the standards.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.