Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Recruiting
Observational Study
Movement DisordersParkinson DiseaseEssential TremorTremorDystoniaPrimary DystoniaSecondary Dystonia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for
This trial is looking for people who need deep brain stimulation surgery for conditions like Parkinson's disease or tremors. Participants will help evaluate the long-term safety and effectiveness of the Abbott DBS system.
Are You a Good Fit for This Trial?
You may be able to join if
I need a new Abbott DBS system implant or device replacement within 180 days.
I can provide written consent for participation.
You may not be able to join if
I am currently in another study that may affect the results.
I have other medical or psychological conditions affecting my participation.
I will get my implant in the US and it is not for Parkinson's or tremors.
I will get my implant in the US and the implant will not be near the STN, GPi, or VIM thalamus.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
Exclusion Criter…
Inclusion Criteria:
1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
Exclusion Criteria:
1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.
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