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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02046863
Other study ID # 1R43NS081902-01
Secondary ID 1R43NS081902
Status Completed
Phase N/A
First received December 5, 2013
Last updated April 26, 2016
Start date November 2013
Est. completion date August 2014

Study information

Verified date April 2016
Source Great Lakes NeuroTechnologies Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Automated Programming
Prototype DBS-Expert software will be used to guide a clinician through DBS programming.

Locations

Country Name City State
United States University of Cincinnati Department of Neurology Cincinnati Ohio

Sponsors (3)

Lead Sponsor Collaborator
Great Lakes NeuroTechnologies Inc. National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Unified Parkinson's Disease Rating Scale III Score After Guided DBS Programming Within two days of standard clinical DBS programming session No
Secondary Change from Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming Within two days of standard clinical DBS programming session No
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