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WithdrawnNCT01230151SAGEUpdated Feb 18, 2011

Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease

An interventional study of GUIDE software, Version 0.1 and Clinically defined stimulation parameters in Parkinson's Disease, sponsored by Intelect Medical, Inc.. Withdrawn at 4 sites in United States. Per ClinicalTrials.gov, last updated 2011-02-18.

Sponsored by Intelect Medical, Inc. · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
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Study summary

The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a patient-specific computational model.

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Conditions studied

  • Parkinson's Disease

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Keywords

  • Deep Brain Stimulation
  • DBS
  • Parkinson's disease
  • PD
  • Patients who have a preexisting Deep Brain Stimulation (DBS) system for the treatment of Parkinson's disease (PD)
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In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with Intelect Medical, Inc. as lead sponsor.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient is able and willing to provide informed consent to participate in the study.
  • The patient's implanted DBS system shall be the Medtronic, Inc. Activa® System. The Medtronic Activa System may consists of either, Soletra®, Kinetra® Activa® RC, or Activa® PC Neurostimulator(s) and two DBS Leads (Model 3387 or 3389).
  • Patient shall have bilateral DBS of the subthalamic nucleolus (STN).
  • Patient shall have stable DBS stimulation without changes in stimulation parameters for no less than 3 months prior to enrollment.
  • Patient shall have stable and optimal regimen of antiparkinson drug therapy for no less than 3 months prior to enrollment.
  • Patient, and caregiver if applicable, is able and willing to be available for study visits throughout the duration of the study (e.g. no planned relocation of residence or extended vacation during the study that would prevent compliance with study visit schedule).
  • Availability, from the patient's medical records, of a Pre-op MRI and high resolution CT with artifact reduction no less than six (6) weeks post-op.
  • Patient shall have Hoehn and Yahr stage III or worse when off stimulation and off medication.
  • Patient shall have demonstrated good response to L-DOPA, defined as no less than a 30% improvement in a UPDRS-III motor exam following the administration of L-DOPA during their screening neurological exam.
  • Patient shall have demonstrated good response to DBS following the administration of DBS while off medication, defined as an improvement in UPDRS-III motor scores better than their improvement to L-DOPA (as determine in above) or no less than 20% worse of an improvement.

Exclusion criteria

Exclusion Criteria:

  • Evidence of secondary or atypical Parkinsonism as suggested by: stroke, encephalitis, exposure to toxins, neuroleptic antipsychotics, neurologic signs of upper motor neuron or cerebellar involvement, or supranuclear palsy.
  • Dementia as evidenced by a mini-mental state examination of 24 or below (MMSE ≥ 24).
  • Prior participation in the Intelect Medical GUIDE study.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Clinical

    Stimulation settings predetermined clinically (Clinical)

    Device: Clinically defined stimulation parameters

  • Experimental
    Model

    stimulation settings derived from a patient-specific computer-based model (Model)

    Device: GUIDE software, Version 0.1

Interventions

  • DeviceGUIDE software, Version 0.1

    The GUIDE software uses computer-based models to determine the spread of stimulation from DBS therapy into surrounding nuclei of the brain. The software models stimulation and is not used to program or communicate with the patient's implanted DBS System. The software was recently validated in a multi-center clinical study.

  • DeviceClinically defined stimulation parameters

    Stimulation parameters clinically determined prior to start of clinical study

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What researchers measure

Primary outcomes

  1. sustained improvement in working memory

    The primary endpoint of this study is to determine whether or not sustained improvement in working memory can be obtained during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical).

    Time frame: 2 Months

Secondary outcomes

  1. Quality of Life (QOL)improvements

    The secondary endpoints will evaluate whether or not sustained cognitive improvements translate into other aspects of the patient's life (e.g. mood, activities of daily living, apathy, etc.) during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical).

    Time frame: 2 Months

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Study locations

4 sites
  • University of Florida
    Gainesville, Florida 32610, United States
  • North Shore University Hospital
    Manhasset, New York 11030, United States
  • Evergreen Healthcare
    Kirkland, Washington 98034, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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References and documents

Publications

  • Frankemolle AM, Wu J, Noecker AM, Voelcker-Rehage C, Ho JC, Vitek JL, McIntyre CC, Alberts JL. Reversing cognitive-motor impairments in Parkinson's disease patients using a computational modelling approach to deep brain stimulation programming. Brain. 2010 Mar;133(Pt 3):746-61. doi: 10.1093/brain/awp315. Epub 2010 Jan 7. PubMed 20061324 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01230151
Lead sponsor
Intelect Medical, Inc.
First posted
Oct 28, 2010
Start date
Dec 2010
Primary completion
Dec 2011 (estimated)
Last update
Feb 18, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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