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Udall Project 1 Aim 4

Udall Project 1 Aim 4

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05568199
Enrollment
100
Registered
2022-10-05
Start date
2024-03-05
Completion date
2027-03-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Brain Stimulation, Parkinsons Disease

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.

Interventions

None listed

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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 * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Motor association with pathway activation patterns6 months post surgeryassociate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.
Cognitive outcome 1 association with pathway activation pattern6 months post surgeryassociate 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.
Cognitive outcome 2 association with pathway activation pattern6 months post surgeryassociate 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 3 association with pathway activation pattern6 months post surgeryassociate 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 4 association with pathway activation pattern6 months post surgeryassociate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Apathy Scale total scores.

Countries

United States

Contacts

CONTACTNiecy Beltz
beltz070@umn.edu612-626-5711
PRINCIPAL_INVESTIGATORJerrold Vitek, MD, PhD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026