Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Abbott Medical Devices
Study ID
NCT04071847
Status
Recruiting
Apply to this trial

Conditions

  • Dystonia
  • Essential Tremor
  • Movement Disorders
  • Parkinson Disease
  • Primary Dystonia
  • Secondary Dystonia
  • Tremor

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation (DBS) — DEVICE
    Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia

Study Details

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

Key Dates

Start date
Nov 26, 2019
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Deep brain stimulation
    Subjects implanted with an Abbott DBS system

Primary Outcome Measure

Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
University of Aizona Health SciencesTucsonArizona85274-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of California at DavisSacramentoCalifornia95817-
Colorado NeurodiagnosticsLittletonColorado80120-
Neurosurgery OneLittletonColorado80122-
University of Miami HospitalMiamiFlorida33136-
University of South Florida - Department of NeurologyTampaFlorida33612
Konrad Bach
[email protected]
727-798-3789
Yarema Bezchlibnyk, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Neepa Patel
[email protected]
312-563-2900
Kristy Urquhart
[email protected]
Neepa Patel, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Elizabeth Zauber, MD
[email protected]
Andrea Hurt, RC
[email protected]
Kansas University Medical CenterKansas CityKansas66160-
University of LouisvilleLouisvilleKentucky40202
Anna Williford
[email protected]
502-852-7402
Joseph Neimat, MD (PRINCIPAL_INVESTIGATOR)
Willis-Knighton Medical CenterShreveportLouisiana71103-
Beth Israe Deaconess Medical CenterBostonMassachusetts02215-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Albany Medical CenterAlbanyNew York12208
Adam Octavian, MD
[email protected]
518-262-6611
Margaret Czerwinski, RN
[email protected]
518 262 0034
The Cleveland Clinic FoundationClevelandOhio44106
Sean Nagel, MD
216-444-2200
Ohio State MedicalColumbusOhio43210
Barbara Changizi, MD
614-366-2420
Wright State University & Premier HealthFairbornOhio45324-
Center for Interventional Pain & SpineExtonPennsylvania19341-
Thomas Jefferson Department or NeurosurgeryPhiladelphiaPennsylvania19107-
Allegheny General Hospital Department of NeurosurgeryPittsburghPennsylvania15212-
Texas Movement Disorder SpecialistGeorgetownTexas78628-
University of Utah HospitalSalt Lake CityUtah84132
Julianna Dorsch
[email protected]
801-587-8804
Paolo Moretti, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Aizona Health Sciences· Tucson, AZCedars-Sinai Medical Center· Los Angeles, CAUniversity of California at Davis· Sacramento, CAColorado Neurodiagnostics· Littleton, CONeurosurgery One· Littleton, COUniversity of Miami Hospital· Miami, FL

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