Udall Project 1 Aim 4

NCT05568199 | Recruiting

• 1 other identifier: STUDY00007781
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Motor association with pathway activation patterns

  associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.

  6 months post surgery

• Cognitive outcome 1 association with pathway activation pattern

  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.

  6 months post surgery

• Cognitive outcome 2 association with pathway activation pattern

  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.

  6 months post surgery

• Cognitive outcome 3 association with pathway activation pattern

  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

  6 months post surgery

• Cognitive outcome 4 association with pathway activation pattern

  associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Apathy Scale total scores.

  6 months post surgery

Study Arms (3)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants are identified by clinicians and trained research personnel through the movement disorder clinic. Patients are identified during the University of Minnesota DBS surgery candidacy evaluation process.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jerrold Vitek, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niecy Beltz

CONTACT

612-626-5711; beltz070@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 5, 2022
• Study Start: March 5, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)