NCT02046863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 9, 2016

Completed
Last Updated

September 22, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

December 5, 2013

Results QC Date

June 27, 2016

Last Update Submit

August 15, 2016

Conditions

Parkinson's DiseaseTremorBradykinesia

Keywords

Parkinson's diseaseTremorBradykinesiaDeep brain stimulationKinesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within two days of standard clinical DBS programming session

Study Arms (1)

Automated Programming

EXPERIMENTAL

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

Interventions

Automated ProgrammingDEVICE

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

Automated Programming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of idiopathic Parkinson's disease
  • Implanted deep brain stimulation system awaiting initial programming session

You may not qualify if:

  • Subjects with significant psychiatric illness or dementia
  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Department of Neurology

Cincinnati, Ohio, 45267, United States

Location

Related 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 Dec 1.

    PMID: 26621764RESULT

MeSH Terms

Conditions

Parkinson DiseaseTremorHypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Biomedical Research Manager
Organization
Great Lakes NeuroTechnologies Inc
dheldman@glneurotech.com
2163615410

Study Officials

  • Dustin A Heldman, PhD

    Great Lakes NeuroTechnologies

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

January 28, 2014

Study Start

November 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 22, 2016

Results First Posted

August 9, 2016

Record last verified: 2016-08

Locations

US(1)