Udall Project 1 Aim 4

Deep Brain Stimulation Clinical Trial

Official title:

Udall Project 1 Aim 4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568199
• Other study ID #: STUDY00007781
• Status: Recruiting
• Start date: March 5, 2024
• Est. completion date: January 1, 2035

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Niecy Beltz
• Phone: 612-626-5711
• Email: beltz070[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2035
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease
• Parkinsons Disease

Locations

Country	Name	City	State
United States	University Of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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