Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease (SAGE)
17. februar 2011 opdateret af: Intelect Medical, Inc.
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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Gainesville, Florida, Forenede Stater, 32610
- University of Florida
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New York
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Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
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Washington
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Kirkland, Washington, Forenede Stater, 98034
- Evergreen Healthcare
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Clinical
Stimulation settings predetermined clinically (Clinical)
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Stimulation parameters clinically determined prior to start of clinical study
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Eksperimentel: Model
stimulation settings derived from a patient-specific computer-based model (Model)
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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sustained improvement in working memory
Tidsramme: 2 Months
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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).
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2 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of Life (QOL)improvements
Tidsramme: 2 Months
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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).
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2 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2010
Primær færdiggørelse (Forventet)
1. december 2011
Datoer for studieregistrering
Først indsendt
27. oktober 2010
Først indsendt, der opfyldte QC-kriterier
27. oktober 2010
Først opslået (Skøn)
28. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. februar 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. februar 2011
Sidst verificeret
1. februar 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 017-0002
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