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

Parkinson's Disease Clinical Trial

— SAGE  

Official title:

Sustained Affect of GUIDE (SAGE):A Software Evaluation Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01230151
• Other study ID #: 017-0002
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2010
• Last updated: February 17, 2011
• Start date: December 2010

Study information

• Verified date: February 2011
• Source: Intelect Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 80
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• GUIDE 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.
• Clinically defined stimulation parameters
Stimulation parameters clinically determined prior to start of clinical study

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Evergreen Healthcare	Kirkland	Washington
United States	North Shore University Hospital	Manhasset	New York
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Intelect Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 Months	No
Secondary	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).	2 Months	No

External Links

•   Sponsor website