Pilot Study for Automated Deep Brain Stimulation Programming

Parkinson's Disease Clinical Trial

Official title:

DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I

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

• Bradykinesia
• Parkinson Disease
• Parkinson's Disease
• Tremor

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