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Pilot Study for Automated Deep Brain Stimulation Programming

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ClinicalTrials.gov Identifier: NCT02046863
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : August 9, 2016
Last Update Posted : September 22, 2016
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Tremor Bradykinesia Device: Automated Programming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I
Study Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: 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.
Device: Automated Programming
Prototype DBS-Expert software will be used to guide a clinician through DBS programming.




Primary Outcome Measures :
  1. Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming [ Time Frame: Within two days of standard clinical DBS programming session ]
    Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046863


Locations
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United States, Ohio
University of Cincinnati Department of Neurology
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Investigators
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Principal Investigator: Dustin A Heldman, PhD Great Lakes NeuroTechnologies

Publications of Results:
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Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT02046863     History of Changes
Other Study ID Numbers: 1R43NS081902-01 ( U.S. NIH Grant/Contract )
1R43NS081902 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2014    Key Record Dates
Results First Posted: August 9, 2016
Last Update Posted: September 22, 2016
Last Verified: August 2016
Keywords provided by Great Lakes NeuroTechnologies Inc.:
Parkinson's disease
Tremor
Bradykinesia
Deep brain stimulation
Kinesia
Additional relevant MeSH terms:
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Parkinson Disease
Tremor
Hypokinesia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms