Parkinson's DiseaseSAGENCT01230151
Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
A study testing GUIDE software, Version 0.1 and Clinically defined stimulation parameters in people with Parkinson's Disease, run by Intelect Medical, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- GUIDE software, Version 0.1 and Clinically defined stimulation parameters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Florida
Gainesville, Florida, 32610
Evergreen Healthcare
Kirkland, Washington, 98034
North Shore University Hospital
Manhasset, New York, 11030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Sustained Affect of GUIDE (SAGE):A Software Evaluation Study
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.
- Conditions
- Parkinson's Disease
- Being tested
- GUIDE software, Version 0.1, Clinically defined stimulation parameters
- 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)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIDE software, Version 0.1Device
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 parametersDevice
Stimulation parameters clinically determined prior to start of clinical study
| Study group | Role | What they receive |
|---|---|---|
| Clinical | Active comparator | Stimulation settings predetermined clinically (Clinical) Receives: Device: Clinically defined stimulation parameters |
| Model | Experimental | stimulation settings derived from a patient-specific computer-based model (Model) Receives: Device: GUIDE software, Version 0.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
Why it stopped: Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelect Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230151
- Sponsor's protocol ID
- 017-0002
- Acronym
- SAGE
- Status last verified
- Feb 2011
- First submitted
- 27 Oct 2010
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Affect of GUIDE (SAGE):A Software Evaluation Study
- ClinicalTrials.gov ID
- NCT01230151
- Acronym / sponsor ID
- SAGE / 017-0002
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Intelect Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical | Active comparator | Device: Clinically defined stimulation parametersStimulation settings predetermined clinically (Clinical) |
| Model | Experimental | Device: GUIDE software, Version 0.1stimulation settings derived from a patient-specific computer-based model (Model) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUIDE software, Version 0.1The 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. | Device | Model |
| Clinically defined stimulation parametersStimulation parameters clinically determined prior to start of clinical study | Device | Clinical |
Primary outcome
sustained improvement in working memory
Time frame: 2 Months
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).
1 secondary outcome
Quality of Life (QOL)improvements
Time frame: 2 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
- Background: PubMed 20061324Frankemolle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUIDE software, Version 0.1 and Clinically defined stimulation parameters in people with Parkinson's Disease, run by Intelect Medical, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained improvement in working memory (time frame: 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.