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

Sponsor: Abbott Medical Devices

NCT ID: NCT04071847

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Deep Brain Stimulation (DBS) (device)
How long the study runs
Study runs about 130 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Abbott Medical Devices, looks at outcomes over time for people with movement disorders such as Parkinson's disease, essential tremor, tremor and dystonia who receive an Abbott deep brain stimulation (DBS) system. It follows people having a new implant or a replacement of their battery device (called an IPG, or implanted pulse generator).

Who can take part

  • You are due to have a new DBS implant or a replacement of your IPG device with an approved Abbott DBS system within 180 days.
  • You (or a legally acceptable representative) give written informed consent before any study-related procedure.

Who may not be able to

  • You are taking part, or plan to take part, in another research study that could affect this study's results.
  • You have health, social or psychological conditions that, in the researcher's opinion, could limit your ability to take part or attend follow-up visits.
  • If the study centre is in the United States: your DBS implant is not for Parkinson's disease or disabling tremor.
  • If the study centre is in the United States: the planned lead placement is not at or near the STN, GPi or VIM thalamus (specific brain areas targeted in DBS).

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
Not specified
Who
All
Number of participants
1,000
Started
2019-11-26
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for movement disorders
  • • Clinical study - 1,000 participants
  • • 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

Who can take part?

  • • Adults
  • • Diagnosed with movement disorders

Where?

  • • Liverpool - The Walton Centre
  • • Bristol - Southmead Hospita
  • • Glasgow - Queen Elizabeth University Hospital
  • • London - King's College Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice. Subjects will be followed for 5 years after the initial programming visit.

Movement DisordersParkinson DiseaseEssential TremorTremorDystoniaPrimary DystoniaSecondary Dystonia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Not specified
  • Who can join: All genders

What the study is looking for

  • ✓Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system...
  • ✓Subject, or a legally acceptable representative, must provide written agreement to take part prior to any study-related...

Who cannot take part

  • ✗Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this...
  • ✗Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling...
See the full 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 Is This Study? (4 UK sites)

The Walton Centre

Liverpool L9 7LJ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Jonathan McGregor

wcft.rdi@nhs.net0151 556 3748

Southmead Hospita

Bristol BS10 5NB, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Victoria MarshallPrincipal Investigator

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Keyoumars AshkanPrincipal Investigator

How to Get in Touch

Claudia Salazar, PhD

Sponsor contact

CONTACT

+1-650-647-3396 claudia.salazar4@abbott.com

Shirisha Chiluka

Sponsor contact

CONTACT

972-526-4820 Shirisha.Chiluka@abbott.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01