Clinical trial NCT05658302: Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst
Official title: Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients

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.

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

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
* 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

Primary outcomes:
measure: reach-related modulation
timeFrame: 2 days
measure: N-back task trials
timeFrame: 2 days
measure: rigidity and bradykinesia assessments
timeFrame: 1 day
measure: peak frequency of the ERs + spontaneous LFPs
timeFrame: 1 day
Secondary outcomes:
measure: N-back task trials
timeFrame: 2 days
measure: rigidity/bradykinesia measurements and correlations to conditions
timeFrame: 1 day
measure: task vs. rest and topographical location
timeFrame: 2 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
Study officials:
References: