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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05568199
Other study ID # STUDY00007781
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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