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

Primary Purpose

Parkinson's Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GUIDE software, Version 0.1

Clinically defined stimulation parameters

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring 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)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Florida
North Shore University Hospital
Evergreen Healthcare
Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clinical

Model

Arm Description

Stimulation settings predetermined clinically (Clinical)

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01230151

First Posted

October 27, 2010

Last Updated

February 17, 2011

Sponsor

Intelect Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01230151

Brief Title

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

Acronym

SAGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Intelect Medical, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

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)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clinical

Arm Type

Active Comparator

Arm Description

Stimulation settings predetermined clinically (Clinical)

Arm Title

Model

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

GUIDE software, Version 0.1

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Clinically defined stimulation parameters

Intervention Description

Stimulation parameters clinically determined prior to start of clinical study

Primary Outcome Measure Information:

Title

sustained improvement in working memory

Description

Time Frame

2 Months

Secondary Outcome Measure Information:

Title

Quality of Life (QOL)improvements

Description

Time Frame

2 Months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

North Shore University Hospital

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Evergreen Healthcare

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20061324

Citation

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.

Results Reference

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

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