Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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
Primary outcome measures
- reach-related modulation [Time frame: 2 days]
- N-back task trials [Time frame: 2 days]
- rigidity and bradykinesia assessments [Time frame: 1 day]
- peak frequency of the ERs + spontaneous LFPs [Time frame: 1 day]
Secondary outcome measures (3)
- N-back task trials [Time frame: 2 days]
- rigidity/bradykinesia measurements and correlations to conditions [Time frame: 1 day]
- task vs. rest and topographical location [Time frame: 2 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University Of Minnesota — Minneapolis
Identifiers
NCT: NCT05658302 · STUDY00015253