Udall Project 1 Aim 4
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other significant neurological disorder, as determined by PI
Diagnosis of dementia
Pregnant
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 3 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Trial outcomes
Primary outcomes
1
Motor association with pathway activation patterns
associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.
Time frame
6 months post surgery2
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.
Time frame
6 months post surgery3
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.
Time frame
6 months post surgery4
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
Time frame
6 months post surgerySponsors and contacts
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Source ClinicalTrials.gov