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Clinical Trials/NCT03079037
NCT03079037
Completed
Not Applicable

Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

University of Minnesota1 site in 1 country15 target enrollmentJune 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Minnesota
Enrollment
15
Locations
1
Primary Endpoint
Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.

Registry
clinicaltrials.gov
Start Date
June 19, 2018
End Date
January 29, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of idiopathic PD
  • DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.

Exclusion Criteria

  • Other significant neurological disorder
  • History of dementia
  • Prior history of stereotactic neurosurgery
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women

Outcomes

Primary Outcomes

Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication

Time Frame: 2 days

Clinical ratings scales (MDS-UPDRS)

Study Sites (1)

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