Home › Trials › NCT04071847

Long-term evaluation of Abbott deep brain stimulation systems for movement disorders

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

Observational Abbott Medical Devices · NCT04071847

This study is testing how safe and effective Abbott deep brain stimulation systems are for people with movement disorders like Parkinson's disease over a five-year period.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations48 sites (Tucson, Arizona and 47 other locations)
Trial IDNCT04071847 on ClinicalTrials.gov

What this trial studies

This international, multicenter observational study aims to assess the long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems in patients with movement disorders such as Parkinson's disease and essential tremor. Participants will be followed for five years after their initial programming visit to gather data on outcomes in routine clinical practice. The study includes subjects who are scheduled for a new implant or replacement surgery with Abbott DBS systems and requires informed consent prior to participation.

Who should consider this trial

Good fit: Ideal candidates are individuals scheduled for a new implant or replacement surgery with a market-released Abbott DBS system for conditions like Parkinson's disease or essential tremor.

Not a fit: Patients currently enrolled in other investigational studies or those with certain comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term benefits and risks of DBS therapy for patients with movement disorders.

How similar studies have performed: Other studies have shown positive outcomes with deep brain stimulation for movement disorders, indicating that this approach has been successful in the past.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Tucson, Arizona and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Movement DisordersParkinson DiseaseEssential TremorTremorDystoniaPrimary DystoniaSecondary Dystonia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.