Real-world multicenter assessment of sustained clinical outcomes after digital deep brain stimulation.
Alireza Gharabaghi, Sergiu Groppa, Elena Casas...
https://pubmed.ncbi.nlm.nih.gov/41535352Actively Recruiting
All Genders
ID04071847
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Led by Abbott Medical Devices · Updated on 2026-01-08
1000
Participants Needed
48
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems used for various movement disorders, including Parkinson's disease, essential tremor, disabling tremor, and dystonia. This international, prospective, multicenter study collects data from patients implanted with Abbott DBS devices during routine clinical care to understand outcomes over time. Participants implanted with the Abbott DBS system will be observed without altering their treatment, as this is an observational study. The study follows subjects for five years from their initial programming visit to gather information on device performance and patient motor function over time. During the study, participants will have regular assessments using disease-specific motor rating scales such as MDS-UPDRS Part III for Parkinson's disease and FTM-TRS for tremor. Researchers will monitor changes in motor symptoms and record any serious device- or procedure-related adverse events. Study involvement lasts for five years, allowing long-term collection of safety and effectiveness data.
CONDITIONS
Brief Title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Scheduled for a new implant or implantable pulse generator replacement surgery with a market-released Abbott DBS system within 180 days
- Able to provide written informed consent or have a legally acceptable representative provide consent before any study procedures
You will not qualify if you...
- Currently enrolled or planning to enroll in an investigational study that could affect this study's results
- Having medical, social, psychological, or anatomical conditions that limit participation or compliance with follow-up
- For US centers: indication for DBS implant is not Parkinson's disease or disabling tremor
- For US centers: intended lead implant location is not at or near the STN, GPi, or VIM thalamus areas of the brain
- Any condition that, in the investigator's opinion, may impact the scientific validity of the study results or participant safety or compliance with the study requirements or follow-up visits
- Subjects unable to comply with study follow-up requirements or procedures as determined by the investigator
- Subjects with other medical or psychological conditions that may interfere with participation or study results as judged by the investigator
- Subjects with anatomic conditions limiting study participation as judged by the investigator
- Subjects with social conditions limiting study participation as judged by the investigator
- Subjects with psychological conditions limiting study participation as judged by the investigator
- Subjects enrolled in conflicting studies that may confound results in this study
- Subjects at US sites with DBS indication or lead location outside specified criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 180 days before implantation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Implementation
Duration - Day of surgery
Participants receive implantation or implantable pulse generator replacement surgery with an Abbott DBS system as part of routine clinical care.
1 implantation visit (in-person)
Monitoring
Duration - Up to 5 years after implantation
Participants are followed for long-term safety and effectiveness of the Abbott DBS system with scheduled assessments of motor function and adverse events.
Visits at baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Trial Site Locations
Total: 48 locations
1
University of Aizona Health Sciences
Tucson, Arizona, United States, 85274
Active, Not Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
3
University of California at Davis
Sacramento, California, United States, 95817
Active, Not Recruiting
4
Colorado Neurodiagnostics
Littleton, Colorado, United States, 80120
Terminated
5
Neurosurgery One
Littleton, Colorado, United States, 80122
Withdrawn
6
University of Miami Hospital
Miami, Florida, United States, 33136
Active, Not Recruiting
7
University of South Florida - Department of Neurology
Tampa, Florida, United States, 33612
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Active, Not Recruiting
11
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
Willis-Knighton Medical Center
Shreveport, Louisiana, United States, 71103
Terminated
13
Beth Israe Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
14
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Active, Not Recruiting
15
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
16
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44106
Actively Recruiting
17
Ohio State Medical
Columbus, Ohio, United States, 43210
Actively Recruiting
18
Wright State University & Premier Health
Fairborn, Ohio, United States, 45324
Withdrawn
19
Center for Interventional Pain & Spine
Exton, Pennsylvania, United States, 19341
Withdrawn
20
Thomas Jefferson Department or Neurosurgery
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
21
Allegheny General Hospital Department of Neurosurgery
Pittsburgh, Pennsylvania, United States, 15212
Terminated
22
Texas Movement Disorder Specialist
Georgetown, Texas, United States, 78628
Active, Not Recruiting
23
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
24
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
25
Royal Melbourne Hospital - City Campus
Parkville, Victoria, Australia, 3050
Actively Recruiting
26
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00290
Actively Recruiting
27
CHU Gabriel Montpied
Clermont-Ferrand, Auvergne, France, 63003
Withdrawn
28
CHU de St Etienne
Saint-Etienne, Auvergne, France, 42270
Active, Not Recruiting
29
Fondation Rothchild
Paris, ILE, France
Withdrawn
30
CHU Hopital Pasteur
Nice, Provence-Alpes-Azur, France, 6002
Actively Recruiting
31
Universitäts Klinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
32
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
33
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
34
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
35
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421
Actively Recruiting
36
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg, Germany, 20246
Active, Not Recruiting
37
Az.Osp. Universitaria di Ferrara
Cona, Emilia-Romagna, Italy, 44124
Terminated
38
Policlinico Universitario A. Gemelli
Rome, Lazio, Italy, 00618
Actively Recruiting
39
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy, 20133
Active, Not Recruiting
40
Hospital Virgen de Rocio
Seville, Andalusia, Spain, 41013
Actively Recruiting
41
Hospital Universitari Germans Trias I Pujol
Badalona, Catalonia, Spain, 08916
Actively Recruiting
42
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Actively Recruiting
43
Chang Gung Memorial Hospital
Linkou District, Ntaiwan, Taiwan, 333
Active, Not Recruiting
44
Hualien Tzu Chi Hospital
Hualien City, Taiwan, 97002
Actively Recruiting
45
The Walton Centre
Liverpool, North West England, United Kingdom, L9 7LJ
Active, Not Recruiting
46
Southmead Hospita
Bristol, South West England, United Kingdom, BS10 5NB
Withdrawn
47
Queen Elizabeth University Hospital
Glasgow, Wdbtshr, United Kingdom
Actively Recruiting
48
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
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Research Team
C
Claudia Salazar, PhD
S
Shirisha Chiluka
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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