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Taking people in ItalyNo phase

Follows people with movement disorders treated with deep brain stimulation devices

Studies long-term safety of brain stimulation devices in people with Parkinson disease, tremor, or dystonia.

Key facts

Who runs it
Abbott Medical Devices
Where
Cona, Milan, and Rome, ItalySee the 3 sitesAlso in 8 other countries, 45 sites
Trial code
Registry title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Status
Recruiting
People taking part
1,000 people, planned
Started
26 Nov 2019
Expected to end
Sept 2030
Type of study
Observational
Treatments tested
  • Deep Brain Stimulation (DBS)
Record updated
8 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who are about to have a new Abbott deep brain stimulation (DBS) device implanted, or an existing device battery (IPG) replaced.

Sex
All sexes can join.
Earlier treatment
Surgery with a market-released Abbott DBS system must be planned within 180 days.

Main reasons for not taking part

  • Taking part in another investigational study that could affect the results
  • Medical, social or psychological conditions that, in the investigator's opinion, limit taking part or follow-up
  • In US centers: DBS not for Parkinson's disease or disabling tremor
  • In US centers: lead not placed at or near the STN, GPi or VIM thalamus

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days
  • Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure

Who cannot take part

  • 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
  • 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
  • Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor
  • Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study

Where in Italy

Also in 8 other countries, 45 sites

  • Az.Osp. Universitaria di FerraraCona, ItalyContact: Claudia Salazar, PhDNo longer taking part
  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaMilan, ItalyContact: Claudia Salazar, PhDNo longer taking part
  • Policlinico Universitario A. GemelliRome, ItalyContact: Francesco BoveTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Deep brain stimulation

    Subjects implanted with an Abbott DBS system

    Treatment: Deep Brain Stimulation (DBS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Plain-language title
Follows people with movement disorders treated with deep brain stimulation devicesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
8 January 2026