Status:

COMPLETED

Novel DBS Device in Parkinson's Disease

Lead Sponsor:

University of Minnesota

Collaborating Sponsors:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Parkinson's Disease (PD)

Eligibility:

All Genders

22-75 years

Phase:

NA

Brief Summary

The purpose of this research is to test a new recorder that can measure brain activity when stimulation is turned on during deep brain stimulation (DBS) surgery. To continue to improve DBS therapy, th...

Detailed Description

Deep brain stimulation (DBS) is shown to be very effective in alleviating the motor symptoms of Parkinson's disease (PD). However, its exact mechanism is not well-understood. Clinical studies have rep...

Eligibility Criteria

Inclusion

  • Has unilateral STN or GPi DBS and is approved to undergo second or contralateral side implantation;
  • Diagnosis of idiopathic PD;
  • A history of a good response to levodopa (carbidopa/levodopa) defined as at least a 30% improvement in motor unified Parkinson's disease rating scale (UPDRS) score;
  • DBS surgery at UMN is planned as part of routine clinical care.

Exclusion

  • Other significant neurological disorder
  • History of dementia
  • 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

Key Trial Info

Start Date :

July 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 2 2022

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT07213999

Start Date

July 1 2022

End Date

July 2 2022

Last Update

October 9 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455