Pilot Study for Automated Deep Brain Stimulation Programming

NCT ID: NCT02046863

Last Updated: 2016-09-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-08-31

Brief Summary

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The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.

Detailed Description

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Conditions

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Parkinson's Disease Tremor Bradykinesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Automated Programming

Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.

Group Type EXPERIMENTAL

Automated Programming

Intervention Type DEVICE

Prototype DBS-Expert software will be used to guide a clinician through DBS programming.

Interventions

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Automated Programming

Prototype DBS-Expert software will be used to guide a clinician through DBS programming.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of idiopathic Parkinson's disease
* Implanted deep brain stimulation system awaiting initial programming session

Exclusion Criteria

* Subjects with significant psychiatric illness or dementia
* Significant cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Great Lakes NeuroTechnologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dustin A Heldman, PhD

Role: PRINCIPAL_INVESTIGATOR

Great Lakes NeuroTechnologies

Locations

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University of Cincinnati Department of Neurology

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Heldman DA, Pulliam CL, Urrea Mendoza E, Gartner M, Giuffrida JP, Montgomery EB Jr, Espay AJ, Revilla FJ. Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. Neuromodulation. 2016 Feb;19(2):127-32. doi: 10.1111/ner.12372. Epub 2015 Dec 1.

Reference Type RESULT
PMID: 26621764 (View on PubMed)

Other Identifiers

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1R43NS081902

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R43NS081902-01

Identifier Type: NIH

Identifier Source: org_study_id

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