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CompletedNCT01429220Updated Sep 15, 2014

Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming

An observational study in Parkinson's Disease, sponsored by Great Lakes NeuroTechnologies Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-09-15.

Sponsored by Great Lakes NeuroTechnologies Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Ages
21 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's disease patients.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • deep brain stimulation
  • monopolar review
  • motion sensors
  • tremor
  • bradykinesia
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 9 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Great Lakes NeuroTechnologies Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Parkinson's disease

Inclusion criteria

  • Hoehn and Yahr stage 2 or worse when off medications
  • Average tremor and/or bradykinesia Unified Disease Rating Scale (UPDRS) score greater than 2 off meds
  • L-dopa responsive with clearly defined "on" periods, UPDRS motor III average tremor and bradykinesia improves by 25%
  • Stable on medical therapy for at least one month prior to study enrollment
  • Clinical approval to undergo unilateral DBS surgery targeting the STN or GPi
  • Available to participate for six months following DBS surgery

Exclusion criteria

Exclusion Criteria:

  • "Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
  • previous Parkinson's Disease surgery
  • medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
  • contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
  • neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery
  • intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (actual)
06

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01429220
Lead sponsor
Great Lakes NeuroTechnologies Inc.
Responsible party
Sponsor
First posted
Sep 7, 2011
Start date
Aug 2011
Primary completion
Apr 2014
Last update
Sep 15, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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