Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation (CUSTOM-DBS)

17 novembre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Austria
      • Innsbruck, Austria
        • A.o. LKH Univ.-Kliniken Innsbruck
  • Germania
      • Berlin, Germania
        • University Berlin, Charite Virchow
      • Düsseldorf, Germania
        • Universitaetsklinikum Dusseldorf
      • Kiel, Germania
        • Universitätsklinikum Campus Kiel
      • Köln, Germania
        • Uniklinik Koln
      • Wurzburg, Germania
        • Universitaetsklinikum Wuerzburg
  • Italia
      • Udine, Italia
        • Osp. S. Maria Della Misericordia
  • Regno Unito
      • Bristol, Regno Unito
        • Southmead Hospital Bristol
      • London, Regno Unito
        • Charing Cross Hospital
  • Stati Uniti
    • California
      • Valencia, California, Stati Uniti, 91355
        • Boston Scientific Clinical Research Information Toll Free Number

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Short PW
Patients with a Vercise DBS system programmed to 30 microseconds pulse width
Dispositivo: Vercise DBS settings
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Sperimentale: Conventional PW
Patients with a Vercise DBS system programmed to 60 microseconds pulse width
Dispositivo: Vercise DBS settings
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Sperimentale: Ventral current steering
Patients with a Vercise DBS system programmed to steer current ventrally
Dispositivo: Vercise DBS settings
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Sperimentale: Dorsal current steering
Patients with a Vercise DBS system programmed to steer current dorsally.
Dispositivo: Vercise DBS settings
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Therapeutic Window
Lasso di tempo: Day 1 programming visit
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.
Day 1 programming visit
Unified Parkinson's Disease Rating Scale III
Lasso di tempo: Day 1 programming visit

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Side Effect Thresholds - Single Contact vs. Steering
Lasso di tempo: Day 1 programming visit
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).
Day 1 programming visit
Resting Tremor Severity - Single Contact vs. Steering
Lasso di tempo: Day 1 programming visit
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).
Day 1 programming visit
Finger Tapping Amplitude - Single Contact vs. Steering
Lasso di tempo: Day 1 programming visit
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).
Day 1 programming visit

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Dorsal-Ventral Current Steering Therapeutic Window
Lasso di tempo: Day 1 programming visit
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).
Day 1 programming visit
Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering
Lasso di tempo: Day 1 programming Visit
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).
Day 1 programming Visit
Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering
Lasso di tempo: Day 1 programming visit
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).
Day 1 programming visit

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boston Scientific Corporation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2013

Completamento primario (Effettivo)

1 dicembre 2014

Completamento dello studio (Effettivo)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

24 giugno 2013

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2013

Primo Inserito (Stima)

11 luglio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A4009
  • CDM00060272 (Altro identificatore: BSC Protocol Number)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Vercise DBS settings

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Ethiopia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi