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Completed

NCT Number: NCT03079037

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulation

Device

Traditional deep brain stimulation

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2017
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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