Pilot Study for Automated Deep Brain Stimulation Programming

Not Applicable

Completed

• Conditions: Parkinson's Disease; Tremor; Bradykinesia
• Interventions: Device: Automated Programming

• Registration Number: NCT02046863
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2014-01-24
• Study First Posted: 2014-01-28
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2016-06-27
• Results First Submitted QC: 2016-06-27
• Status Verified: 2016-08
• Results First Posted: 2016-08-09
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Automated Programming	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.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming	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.

Trial Locations

Locations (1)

University of Cincinnati Department of Neurology; 🇺🇸 Cincinnati, Ohio, United States