Udall Project 1 Aim 4

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05568199
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 5, 2024
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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: 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
  • Arm: 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: 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
  • Arm: 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: 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

Primary Outcome Measure

Motor association with pathway activation patterns [ Time Frame: 6 months post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Of MinnesotaMinneapolisMinnesota55455-

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By specialty
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By research site
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