Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst

University of Minnesota (UMN)

Status: Enrolling

Conditions: Parkinson Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05658302

STUDY00015253

Details and patient eligibility

About

This study will help us better understand how the brain works in people with Parkinson's disease (PD). PD is a brain disease that gets worse over time, and affects over 10 million people world-wide. A common treatment for PD is Deep Brain Stimulation (DBS). To improve DBS therapy for PD, we need a deeper understanding of how the different parts of the brain work together in PD, and how this relates to movement and thinking problems that people with PD experience.

We may be able to use the results of this study to improve DBS treatments in the future.

Full description

Parkinson's disease (PD) is a progressive neurodegenerative disease affecting over 10 million people world-wide. It can be a debilitating disorder and although studied for decades, the physiological changes in the basal ganglia thalamocortical (BGTC) circuit that underlie its development remain under debate. Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and internal globus pallidus (GPi) has been a highly effective therapy for many patients with PD, however, the results have been highly variable and may be associated with cognitive compromise in some patients. To advance DBS therapies for PD we require a deeper understanding of the local and network-wide circuit dynamics and their relationship to motor signs and cognitive function. This understanding will provide the rationale for optimizing STN and GPi DBS, targeting specific regions within the STN and GPi, and development of patient-specific DBS based on the patients' motor signs and cognitive profile

Enrollment: 30 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic PD
• Surgery at UMN to implant DBS system with directional lead(s) and multiple independent current control IPG is planned as part of routine clinical care
• At least 21 years old
• Existing or planned 7T brain imagery

Exclusion criteria

• Other significant neurological disorder
• History of dementia
• Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
• Pregnant women
• Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

Trial design

30 participants in 1 patient group

Parkinson's disease

Description:

* Diagnosis of idiopathic PD * Surgery at UMN to implant DBS system with directional lead(s) and multiple independent current control IPG is planned as part of routine clinical care * At least 21 years old * Existing or planned 7T brain imagery