Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05568199

Conditions

Parkinsons Disease

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Parkinsons Disease

Deep Brain Stimulation

Study ID

NCT05568199

Start date

Mar 5, 2024

Status verified date

Apr, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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 ]
  • Cognitive outcome 1 association with pathway activation pattern [ Time Frame: 6 months post surgery ]
  • Cognitive outcome 2 association with pathway activation pattern [ Time Frame: 6 months post surgery ]
  • Cognitive outcome 3 association with pathway activation pattern [ Time Frame: 6 months post surgery ]
  • Cognitive outcome 4 association with pathway activation pattern [ Time Frame: 6 months post surgery ]

Central Contacts and Locations

Central contacts

Niecy Beltz

612-626-5711beltz070@umn.edu

Locations

University Of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-08.