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Pilot Study for Automated Deep Brain Stimulation Programming

Primary Purpose

Parkinson's Disease, Tremor, Bradykinesia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Automated Programming

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's disease, Tremor, Bradykinesia, Deep brain stimulation, Kinesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Cincinnati Department of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Automated Programming

Arm Description

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02046863

First Posted

December 5, 2013

Last Updated

August 15, 2016

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT02046863

Brief Title

Pilot Study for Automated Deep Brain Stimulation Programming

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Tremor, Bradykinesia

Keywords

Parkinson's disease, Tremor, Bradykinesia, Deep brain stimulation, Kinesia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Automated Programming

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Automated Programming

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming

Description

Time Frame

Within two days of standard clinical DBS programming session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dustin A Heldman, PhD

Organizational Affiliation

Great Lakes NeuroTechnologies

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati Department of Neurology

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26621764

Citation

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.

Results Reference

result

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Pilot Study for Automated Deep Brain Stimulation Programming

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