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Predictive Factors of Short/Long-term Outcome and Complications of Bilateral DBS in PD (PREDIMPSTIM)

28. januar 2019 oppdatert av: University Hospital, Grenoble

Étude Des Facteurs prédictifs Des Effets Cliniques et Des Complications à Court et Long Terme de la Stimulation cérébrale Profonde Des Noyaux Sous-thalamiques Dans la Maladie de Parkinson

The purpose and main objective of this study is the research of pre-operative and operative predictive factors of short-term (1-year) and long-term (15-years) improvement of quality of life, motor and non-motor symptoms in Parkinson's disease patients who have undergone to bilateral Subthalamic Nucleus Deep Brain Stimulation.

The hypothesis of the study is that the definition of pre-operative and operative predictive factors could be able to improve the pre-operative prognostic accuracy of outcome and complications after surgery, allowing also a better selection of the most suitable candidates for bilateral Subthalamic Nucleus Deep Brain Stimulation.

For example, we can suppose that an older age at surgery, elevated axial score, a less preoperative dopa-responsiveness, the presence of mild executive dysfunction at surgery or an unfavourable social status, could negatively influence the short and long term surgery outcome

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Subthalamic NucleusDeep Brain Stimulation (STN-DBS) represents a short and long-term effective treatment in Parkinson's disease (PD) patients. Various randomized controlled trials have confirmed the superiority of STN-DBS compared to the best medical treatment in patients with advanced Parkinson disease in term of improvement of motor function and quality of life. On the other hand, STN- DBS is associated with an increased risk of adverse events compared to best medical treatment.

Data from previous meta-analysis have shown that only pre-operative dopa-responsiveness can predict the clinical efficacy and outcome of STN-DBS. In particular the improvement of STN-DBS on quality of life mainly concern the physical aspects of functioning with a lower improvement on social and cognitive aspects.

However, not all of PD symptoms respond similarly to STN-DBS. In particular the effects of STN-DBS on the so-called levodopa unresponsive symptoms (i.e. gait and balance symptoms, autonomic dysfunction, sleep disorders, cognitive decline and speech and swallowing troubles) are modest or absent. Furthermore, levodopa unresponsive symptoms are one of the main causes of impairment and disability in advanced PD patients. Bearing in mind these informations, the clinical phenotyping of candidates for surgery appear crucial for the prediction of DBS outcome and selection of better candidates. In the recent years, several papers highlighted and expanded the list of possible predictive factors, from a motor point of view to non-motor symptoms and psychosocial aspects.

In this setting, the aim of our study is to determine the pre-operative and operative short-term (1-year) and long-term (15-years) predictive factors of improvement of quality of life and motor and non-motor symptoms in a large cohort of PD patients who have undergone to bilateral STN-DBS. The better definition of short-term and long-term predictive factors and its association with the different PD different clinical phenotypes could allow in the future a better definition of the effects of STN-DBS on quality of life and motor and non-motor symptoms in the different PD clinical phenotypes.

In the same way, it could be assumed that a better definition of pre-operative predictive factors of surgical, hardware and stimulation-induced STN-DBS side effects in the short term, could also allow a better definition of the risk-to-benefit ratio and outcome after STN-DBS surgery

Studietype

Observasjonsmessig

Registrering (Faktiske)

420

Kontakter og plasseringer

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

Studiesteder

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

30 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patient with Parkinson's disease treated with bilateral Subthalamic Nucleus Deep Brain Stimulation

Beskrivelse

Inclusion Criteria:

  • Patients with Parkinson's disease treated with bilateral Subthalamic Nucleus Deep Brain Stimulation

Exclusion Criteria:

  • Patients treated with bilateral Subthalamic Nucleus Deep Brain Stimulation not affected by Parkinson's Disease
  • Patients with Parkinson's disease treated with unilateral Subthalamic Nucleus Deep Brain Stimulation

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in the Unified Parkinson's Disease Rating Scale (UPDRS) section I, II, III, IV, V, VI scores
Tidsramme: pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
The Unified Parkinson's Disease Rating Scale (UPDRS) has been developed for the clinical evaluation of Parkinson's disease (PD) patients. It allows the assessment of both motor and non-motor symptoms associated with PD
pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients that developed Treatment-Related (drug-related or DBS-related) complications
Tidsramme: 1 year after bilateral Subthalamic Nucleus Deep Brain Stimulation

Surgical-related complications, post-operative complications related to DBS devices and hardware, complications related to STN stimulation or drug administration.

Post-operative complications directly related to STN stimulation.

1 year after bilateral Subthalamic Nucleus Deep Brain Stimulation
Changes in the Parkinson's Disease Questionnaire (PDQ-39) total score and different subscale scores (Mobility; Activities of daily living; Emotional well being; Stigma; Social Support; Cognitions; Communication; Bodily discomfort)
Tidsramme: pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
The Parkinson's Disease Questionnaire (PDQ-39) is a short 39 item self-report health status questionnaire developed for evaluate the quality of life in Parkinson's disease patients.
pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
Changes in the Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II, III, IV scores
Tidsramme: pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation
The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the recent version of the UPDRS revised by the MDS. It allows the assessment of both motor and non-motor symptoms associated with PD
pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Francesco Cavallieri, MD, Chu Grenoble Alpes
  • Studieleder: Elena Moro, MD, PhD, Chu Grenoble Alpes

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)

11. september 2017

Primær fullføring (Faktiske)

4. mai 2018

Studiet fullført (Faktiske)

27. januar 2019

Datoer for studieregistrering

Først innsendt

14. november 2017

Først innsendt som oppfylte QC-kriteriene

4. mai 2018

Først lagt ut (Faktiske)

17. mai 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

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. .

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