Udall Project 1 Aim 4
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cognitive outcome 3 association with pathway activation pattern
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
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:
- clinically-optimized stimulation
- model-based stimulation directed towards motor subregions of STN and GPi
- model-based stimulation directed towards associative/limbic subregions of STN/GPi
Randomized to start with condition1 assessment
Group 2
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:
- clinically-optimized stimulation
- model-based stimulation directed towards motor subregions of STN and GPi
- model-based stimulation directed towards associative/limbic subregions of STN/GPi
Randomized to start with condition 2 assessment
Group 3
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:
- clinically-optimized stimulation
- model-based stimulation directed towards motor subregions of STN and GPi
- model-based stimulation directed towards associative/limbic subregions of STN/GPi
Randomized to start with condition 3 assessment
Outcomes
Primary Outcomes
Cognitive outcome 3 association with pathway activation pattern
Time Frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Beck Depression Inventory (BDI)-II
Cognitive outcome 1 association with pathway activation pattern
Time Frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. One primary cognitive outcome measure will be the D-KEFS Letter Fluency test. Another primary cognitive measure will be the Stroop Color Word total score. Secondary measures will include the Beck Depression Inventory (BDI)-II and Apathy Scale total scores.
Motor association with pathway activation patterns
Time Frame: 6 months post surgery
associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.
Cognitive outcome 2 association with pathway activation pattern
Time Frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will be the Stroop Color Word total score.
Cognitive outcome 4 association with pathway activation pattern
Time Frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Apathy Scale total scores.
Secondary Outcomes
No secondary outcomes reported