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NCT05658302 | RECRUITING | Parkinson Disease

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

University of Minnesota

Brief Summary:

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.

Condition or disease

Parkinson Disease

Detailed 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

Study Type : OBSERVATIONAL
Estimated Enrollment : 30 participants
Official Title : Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst
Actual Study Start Date : 2023-03-28
Estimated Primary Completion Date : 2027-03-01
Estimated Study Completion Date : 2028-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: FEMALE
Criteria
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
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
Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst

Location Details

NCT05658302

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

University Of Minnesota

Minneapolis, Minnesota, United States, 55445