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Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation (Hub&Spoke)

26 april 2017 uppdaterad av: Fenna Phibbs, Vanderbilt University
Outcomes study to test the hypothesis that patients first identified by community-based neurologists, implanted by a networked movement disorders center, and then managed by the same community-based neurologist will have clinical outcomes comparable to movement disorders centers.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The proposed outcomes study is a prospective, randomized, multicenter, single blind, non-inferiority clinical trial comparing the safety and efficacy of deep brain stimulation therapy applied in a community-based model for 62 subjects with Parkinson's disease appropriate for STN DBS therapy.

Eight community-based private neurology practices will be networked to Vanderbilt University Medical Center (VUMC). Neurologists for each practice will attend structured educational programs offered by Medtronic in the identification, selection, and management of Parkinson's disease patients with DBS therapy. Following this educational program, each practice will identify subjects for implantation VUMC. Following screening and baseline visits at VUMC, appropriate patients will be implanted with bilateral subthalamic nucleus deep brain stimulating therapy. The initial post-operative programming will be done at VUMC four weeks after implantation. 8 subjects will then be equally randomized with half being followed for long-term management by the community-based neurologist. The other half will be followed at VUMC.

All subsequent outpatient evaluation management of medications and deep brain stimulation will be managed per standard of care at the location assigned by randomization, community-based private neurology practice or VUMC.

All subjects will be enrolled during the first 24 months of the study. Follow-up evaluations at 12 months will be performed at VUMC. Each patient identified by the community-based neurologist for implantation will be assessed at VUMC. This assessment will include a videotaped off and on UPDRS III rating, neuropsychological testing, and appropriateness as outlined in the patient selection educational program. Patients will be implanted by bilateral subthalamic nucleus deep brain stimulation therapy within 120 days of their initial assessment. The initial post-operative programming will be performed four weeks post-operatively, this is all standard of care.

Subjects will then be randomized to be either managed by their community-based neurologist or at VUMC. Follow-up evaluations at 12 months will include a videotaped on and off UPDRS rating and neuropsychological testing, anti-parkinson medication dosages, and quality of life measures.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Patients must have a clinical diagnosis of probable idiopathic PD. The diagnosis will be based upon the presence of at least three of four clinical features according to diagnostic utility (Resting Tremor, Bradykinesia, Rigidity, Asymmetric Onset) and an absence of clinical features suggestive of an alternative diagnosis.
  2. Demonstrated response to dopaminergic therapy. In order to exclude patients with a possible alternative diagnosis, all subjects included in the study must have demonstrated a good response to DA drugs, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their DA drug(s) during the screening neurological examination.
  3. Advanced Parkinson's disease.
  4. No contraindications to surgery.
  5. Age between 50 and 75 years old.
  6. Available for follow-up for the entire duration of the study.
  7. Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
  8. MRI within normal range for age

Exclusion Criteria:

  1. Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
  2. Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
  3. Evidence of dementia
  4. Major psychiatric disorder
  5. Previous brain operation or injury.
  6. Active participation in another clinical trial for the treatment of PD.
  7. Patients who have demand cardiac pacemakers or who have medical conditions that require repeat MRI scans.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Movement Disorder Center
Device programming, Deep Brain stimulator will be programmed at the implanting center, standard of care
Procedur: Standard of care
Deep Brain Stimulator will be programmed with at the implanting movement disorders center
Experimentell: Programming by community Neurologist
Device programming, Deep Brain Stimulator will be programmed by community Neurologist
Procedur: Programming by community Neurologist
Deep Brain stimulator with be programmed by a community Neurologist

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
UPDRS part IV
Tidsram: one year
Change in score from baseline, complication of medical therapy for Parkinson's disease
one year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
UPDRS
Tidsram: One Year
Change from baseline, composite score of all 4 parts of the UPDRS
One Year
PDQ-39
Tidsram: One year
Change from baseline in quality of life
One year
Obeso Dyskinesia Rating Scale
Tidsram: One year
Change from baseline, involuntary movements caused by Parkinson's disease treatment
One year
Hoehn and Yahr rating
Tidsram: One year
Change from baseline, in stage of disease
One year
Schwab and England ADL score
Tidsram: One year
Change from baseline, signs and symptoms of depression
One year
Parkinson's medication in LEDD
Tidsram: One year
Change from baseline in total Parkinson's disease medications
One year
DBS voltage/current
Tidsram: One year
One year settings of DBS system
One year
DBS electrode configuration
Tidsram: One year
One year settings of DBS system
One year
DBS pulse width
Tidsram: one year
One year settings of DBS system
one year
DBS frequency
Tidsram: one year
One year settings of DBS system
one year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Vanderbilt University

Samarbetspartners

Medtronic

Utredare

  • Huvudutredare: Fenna T Phibbs, MD, Vanderbilt Univeristy Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2016

Primärt slutförande (Förväntat)

1 februari 2017

Avslutad studie (Förväntat)

1 februari 2018

Studieregistreringsdatum

Först inskickad

22 april 2015

Först inskickad som uppfyllde QC-kriterierna

1 september 2015

Första postat (Uppskatta)

4 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 april 2017

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 150174

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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