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Recruiting NCT05568199

Udall Project 1 Aim 4

— Observational Parkinsons Disease Deep Brain Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinsons Disease, Deep Brain Stimulation. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Motor association with pathway activation patterns [Time frame: 6 months post surgery]
  • Cognitive outcome 1 association with pathway activation pattern [Time frame: 6 months post surgery]
  • Cognitive outcome 2 association with pathway activation pattern [Time frame: 6 months post surgery]
  • Cognitive outcome 3 association with pathway activation pattern [Time frame: 6 months post surgery]
  • Cognitive outcome 4 association with pathway activation pattern [Time frame: 6 months post surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University Of Minnesota — Minneapolis

Identifiers

NCT: NCT05568199 · STUDY00007781

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗