CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation (CUSTOM-DBS)
17 november 2020 bijgewerkt door: Boston Scientific Corporation
Current Steering to Optimize Deep Brain Stimulation
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study is a prospective, multi-center, double-blind, randomized controlled trial.
This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Berlin, Duitsland
- University Berlin, Charite Virchow
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Düsseldorf, Duitsland
- Universitaetsklinikum Dusseldorf
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Kiel, Duitsland
- Universitätsklinikum Campus Kiel
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Köln, Duitsland
- Uniklinik Köln
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Wurzburg, Duitsland
- Universitaetsklinikum Wuerzburg
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Udine, Italië
- Osp. S. Maria Della Misericordia
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Innsbruck, Oostenrijk
- A.o. LKH Univ.-Kliniken Innsbruck
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Bristol, Verenigd Koninkrijk
- Southmead Hospital Bristol
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London, Verenigd Koninkrijk
- Charing Cross Hospital
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California
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Valencia, California, Verenigde Staten, 91355
- Boston Scientific Clinical Research Information Toll Free Number
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
- UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
- DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
- Medical and mental fitness to comply with programming visit and study related procedures.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.
Exclusion Criteria:
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
- Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Short PW
Patients with a Vercise DBS system programmed to 30 microseconds pulse width
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Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
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Experimenteel: Conventional PW
Patients with a Vercise DBS system programmed to 60 microseconds pulse width
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Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
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Experimenteel: Ventral current steering
Patients with a Vercise DBS system programmed to steer current ventrally
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Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
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Experimenteel: Dorsal current steering
Patients with a Vercise DBS system programmed to steer current dorsally.
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Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Therapeutic Window
Tijdsspanne: Day 1 programming visit
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The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects.
In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.
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Day 1 programming visit
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Unified Parkinson's Disease Rating Scale III
Tijdsspanne: Day 1 programming visit
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The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings. The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108. |
Day 1 programming visit
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Side Effect Thresholds - Single Contact vs. Steering
Tijdsspanne: Day 1 programming visit
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This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths.
Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).
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Day 1 programming visit
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Resting Tremor Severity - Single Contact vs. Steering
Tijdsspanne: Day 1 programming visit
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Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts.
Stimulation was at amplitudes defined as the therapeutic threshold for rigidity.
The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
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Day 1 programming visit
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Finger Tapping Amplitude - Single Contact vs. Steering
Tijdsspanne: Day 1 programming visit
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Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts.
Stimulation was at amplitudes defined as the therapeutic threshold for rigidity.
The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
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Day 1 programming visit
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Dorsal-Ventral Current Steering Therapeutic Window
Tijdsspanne: Day 1 programming visit
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The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects.
In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).
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Day 1 programming visit
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Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering
Tijdsspanne: Day 1 programming Visit
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Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, at amplitudes defined as the therapeutic threshold for rigidity.
The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
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Day 1 programming Visit
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Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering
Tijdsspanne: Day 1 programming visit
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Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings.
Stimulation was at amplitudes defined as the therapeutic threshold for rigidity.
The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
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Day 1 programming visit
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2013
Primaire voltooiing (Werkelijk)
1 december 2014
Studie voltooiing (Werkelijk)
1 december 2014
Studieregistratiedata
Eerst ingediend
24 juni 2013
Eerst ingediend dat voldeed aan de QC-criteria
10 juli 2013
Eerst geplaatst (Schatting)
11 juli 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 november 2020
Laatste update ingediend die voldeed aan QC-criteria
17 november 2020
Laatst geverifieerd
1 november 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A4009
- CDM00060272 (Andere identificatie: BSC Protocol Number)
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