Udall Project 1 Aim 4

University of Minnesota (UMN)

Status: Enrolling

Conditions: Deep Brain Stimulation; Parkinsons Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05568199

STUDY00007781

Details and patient eligibility

About

By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implanted with a DBS system
• Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
• Diagnosed with idiopathic Parkinson's Disease
• Minimum age 21 years

Exclusion criteria

• Other significant neurological disorder, as determined by PI
• Diagnosis of dementia
• Pregnant

Trial design

100 participants in 3 patient groups

Group 1

Description:

Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition1 assessment

Group 2

Description:

Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition 2 assessment

Group 3

Description:

Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition 3 assessment