Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Relief From Side Effects: Clinical Use of Electrodes With Direction (RESCUED)

6. januar 2019 oppdatert av: Christopher Honey, University of British Columbia

Relief From Side Effects: Clinical Use of Electrodes With Direction: a Prospective, Open Label, Clinical Trial for Thalamic Deep Brain Stimulation

Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in patients with Essential Tremor (ET). The current standard lead allows this stimulation to spread out uniformly in all directions. As these diseases progress, however, the amount of electrical stimulation required to stop the symptom usually increases. This may become problematic because the increased electrical stimulation required for advanced symptoms may spread outside the desired targeted area, and effect other parts of the brain and causing unwanted side effects. A new type of DBS lead has been developed which can steer, or focus, the electrical stimulation in a given direction toward the desired target area and away from areas that would cause side effects. We would like to quantify the benefit seen in patients who have been switched from the traditional lead to this new directional lead.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients implanted with a DBS may experience unwanted side effects such as motor contractures, paresthesia, or dysarthria. This occurs when the electrical field of the stimulation spreads out beyond the targeted area. This is especially common in patients whose disease has progressed, and must use increasingly higher currents in order to regain control of their tremor. Unfortunately, because the electrical field affects neurons in a symmetrical sphere around the DBS, it is often impossible to reach the additional desired neuronal elements without simultaneously affecting equidistant brain regions responsible for side effects. For many of our advanced patients, this means choosing between a debilitating tremor or disabling side effects.The directional lead is a FDA and Health Canada approved DBS lead which features radially segmented electrodes which can selectively steer the electrical field in a predefined direction, orthogonal to the lead trajectory. This will allow DBS clinicians to steer current towards desired structural areas, while avoiding locations, which produce negative side effects.

Studietype

Intervensjonell

Registrering (Forventet)

6

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E3
        • Rekruttering
        • The Vancouver General Hospital
        • Ta kontakt med:

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 til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants must have been implanted with the DBS
  • Participants must have been diagnosed with Essential Tremor
  • Participants must experience negative side effects from their DBS which limit control over their tremor
  • Participants must be able to receive benefit from their stimulator, but at the cost of negative side effects

Exclusion Criteria:

  • All individuals who meet criteria outlined in "inclusion criteria" may be eligible for this study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment
Patients who were previously implanted with a traditional DBS lead and have subsequently developed stimulation induced side effects will gain significantly more tremor control without side effects when re-implanted with a directional DBS lead. We expect these patients' quality of life will improve. These patients typically will have had significant tremor relief (greater than 75% reduction from preoperative tremor rating scale) without side effects at their one year post operative follow-up. With the expected disease progression they will have had to increase their DBS stimulation to the degree that their DBS now causes side effects in order to block their tremor
Annen: No side-effect stimulator settings with directional lead
Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tremor Control
Tidsramme: Assessed once all tests performed - 1 to 2 months post-operatively
Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS "on" versus "off") in each patient using the standard lead compared to the directional lead.
Assessed once all tests performed - 1 to 2 months post-operatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of life based on participant's best real life setting
Tidsramme: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form.
Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
Quality of life based on tremor management participant's best real life setting
Tidsramme: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.
Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
Quality of life based on voice handicap with participant's best real life setting
Tidsramme: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.
Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of British Columbia

Samarbeidspartnere

Boston Scientific Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

17. september 2018

Primær fullføring (Forventet)

1. juli 2019

Studiet fullført (Forventet)

1. august 2019

Datoer for studieregistrering

Først innsendt

17. september 2018

Først innsendt som oppfylte QC-kriteriene

6. januar 2019

Først lagt ut (Faktiske)

8. januar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H17-00672

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Essensiell skjelving

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Kosovo

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere