Using deep brain stimulation to treat cognitive dysfunction in Parkinson's disease

Mechanism and Application of Deep Brain Stimulation in the Treatment of Parkinson's Disease

This study is testing if deep brain stimulation can help improve memory and thinking skills in people with Parkinson's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 50 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06400017 on ClinicalTrials.gov

What this trial studies

This study aims to investigate how electrical stimulation of the substantia nigra can regulate cognitive dysfunction in patients with Parkinson's disease. It employs a self-controlled prospective cohort design, comparing memory performance and brain activity before and after deep brain stimulation (DBS) surgery. The study will involve 60 participants aged 50-70 who meet specific inclusion criteria, and it will analyze the effects of microelectrode stimulation on cognitive functions over time. The goal is to reveal the electrophysiological mechanisms underlying the impact of DBS on memory networks.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50-70 with a clinical diagnosis of typical Parkinson's disease and no significant structural brain changes.

Not a fit: Patients with serious mental or cognitive disorders or those with contraindications for neurosurgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for patients with Parkinson's disease.

How similar studies have performed: Other studies have shown promise in using deep brain stimulation for various symptoms of Parkinson's disease, but the specific focus on cognitive dysfunction is relatively novel.

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 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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: lin shi, M.D.

Conditions: Parkinson's Disease and Parkinsonism, Cognitive dysfunction, Electrical stimulation of substantia nigra