Udall Project 1 Aim 4

Recruiting

• Conditions: Deep Brain Stimulation; Parkinsons Disease

• Registration Number: NCT05568199
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-10-02
• Study First Posted: 2022-10-05
• Study Start: 2024-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2030-01-01
• Study Completion: 2035-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive outcome 3 association with pathway activation pattern	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	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	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	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	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.

Trial Locations

Locations (1)

University Of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States