CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation (CUSTOM-DBS)
17. november 2020 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Valencia, California, Forente stater, 91355
- Boston Scientific Clinical Research Information Toll Free Number
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Udine, Italia
- Osp. S. Maria Della Misericordia
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Bristol, Storbritannia
- Southmead Hospital Bristol
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London, Storbritannia
- Charing Cross Hospital
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Berlin, Tyskland
- University Berlin, Charite Virchow
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Düsseldorf, Tyskland
- Universitaetsklinikum Dusseldorf
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Kiel, Tyskland
- Universitatsklinikum Campus Kiel
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Köln, Tyskland
- Uniklinik Köln
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Wurzburg, Tyskland
- Universitaetsklinikum Wuerzburg
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Innsbruck, Østerrike
- A.o. LKH Univ.-Kliniken Innsbruck
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Therapeutic Window
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Side Effect Thresholds - Single Contact vs. Steering
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Dorsal-Ventral Current Steering Therapeutic Window
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2013
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
24. juni 2013
Først innsendt som oppfylte QC-kriteriene
10. juli 2013
Først lagt ut (Anslag)
11. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A4009
- CDM00060272 (Annen identifikator: BSC Protocol Number)
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