RecruitingOBSERVATIONAL

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

This international study is checking the long-term safety and how well Abbott's Deep Brain Stimulation (DBS) systems work for people with different movement conditions. These include Parkinson's disease, essential tremor (a type of shaking), and dystonia (muscle contractions). The aim is to see how patients get on over several years after having the DBS system fitted. By gathering information from many patients in their everyday health journeys, researchers hope to better understand the lasting effects of this treatment and improve care for people living with these conditions. It's an important step in ensuring these devices continue to provide the best possible support.

At a glance

Status

Recruiting

Sponsor

Abbott Medical Devices

Enrolment target

1,000

Start

26 Nov 2019

Estimated completion

01 Sep 2030

Movement Disorders Parkinson Disease Essential Tremor Tremor Dystonia Primary Dystonia Secondary Dystonia

What is this study about?

This study, called ADROIT, is designed to keep an eye on how people with movement disorders are doing after receiving an Abbott Deep Brain Stimulation (DBS) system. DBS is a treatment where small electrical pulses are sent to specific areas of the brain to help control symptoms like tremors or muscle stiffness. This study is international, meaning it's happening in many different countries, and it's looking at the real-world experiences of patients over a long period.

The main goal is to understand the long-term safety of the DBS system and how effective it is in helping people manage their conditions. Researchers are interested in conditions such as Parkinson's disease, essential tremor (which causes uncontrollable shaking), and dystonia (where muscles contract involuntarily). By collecting information from many people, they can get a clear picture of how well the device works and if there are any long-term effects.

This is not a trial where different treatments are being compared. Instead, it's an observational study, which means doctors are simply watching and recording how patients use the DBS system as part of their usual medical care. The information gathered will help doctors and scientists learn more about DBS and make sure it continues to be a safe and helpful treatment option for people with movement disorders.

Key takeaways

This study looks at how well Abbott DBS systems work long-term.
It's for people with movement disorders like Parkinson's or essential tremor.
It's an 'observational' study, meaning your regular care is monitored.
You'd be followed for up to 5 years to see how you're doing.
The goal is to gather information to improve future DBS treatment.

Who may be eligible?

To be considered for this study, you would either be planning to have a new Abbott DBS system implanted, or you are having an existing Abbott DBS battery (IPG) replaced, within the next 6 months. It's essential that you, or a person legally allowed to make decisions for you, agrees to take part and signs a consent form before any study procedures begin.

You would not be able to join this study if you are already involved in another medical study that might interfere with the results of this one. Also, if your doctor believes certain health issues, social circumstances, or psychological factors would make it difficult for you to participate fully, attend follow-up appointments, or affect the study's accuracy, you would not be eligible.

There are also specific rules if you live in the United States. If you are in the US, your DBS must be for Parkinson's disease or essential tremor, and the lead (the thin wire) needs to be placed in certain well-known areas of the brain related to these conditions. These specific rules don't apply if you're outside the US.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you scheduled for a new Abbott DBS system or a battery replacement soon?
Are you able to provide written agreement to participate?
Are you currently not in another medical study that might affect this one?
If in the US, is your DBS for Parkinson's or essential tremor, and is the lead going to specific brain areas?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will mostly involve your usual clinic visits and check-ups related to your Deep Brain Stimulation (DBS) system. The main commitment is that researchers will follow your progress for up to 5 years after your initial DBS programming visit. They will collect information about how you are doing, how well your DBS is managing your symptoms, and your general health, as part of your routine medical care.

You won't need extra tests or procedures specifically for the study beyond what your doctor would normally recommend for your DBS care. They will simply record information from your regular appointments. The exact number of visits will depend on your individual medical needs, but the study will observe your progress over this 5-year period. You won't be given any new medications or treatments specially for the study; it's all about observing your standard DBS treatment.

Potential risks and benefits

Taking part in this study won't directly improve your health beyond the benefits of your standard DBS treatment, as it's an observational study rather than a new treatment trial. However, the information gathered will help improve future DBS care for others with similar conditions. There are no additional risks from participating in the study itself, beyond the known risks associated with having a DBS system, which your doctor will discuss with you. You always have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (48)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Aizona Health Sciences
Verified postcode
Tucson, United States· Active not recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Active not recruiting
University of California at Davis
Verified postcode
Sacramento, United States· Active not recruiting
Colorado Neurodiagnostics
Verified postcode
Littleton, United States· Terminated
Neurosurgery One
Verified postcode
Littleton, United States· Withdrawn
University of Miami Hospital
Verified postcode
Miami, United States· Active not recruiting
University of South Florida - Department of Neurology
Verified postcode
Tampa, United States· Recruiting
Rush University Medical Center
Verified postcode
Chicago, United States· Recruiting
Indiana University
Verified postcode
Indianapolis, United States· Recruiting
Kansas University Medical Center
Verified postcode
Kansas City, United States· Active not recruiting
University of Louisville
Verified postcode
Louisville, United States· Recruiting
Willis-Knighton Medical Center
Verified postcode
Shreveport, United States· Terminated

Common questions

What is Deep Brain Stimulation (DBS)?

DBS is a treatment for movement problems. It involves a small device placed under your skin that sends electrical pulses to specific areas in your brain to help control symptoms like tremors or muscle stiffness.

Which conditions are being studied?

This study is looking at DBS for people with movement disorders, including Parkinson's disease, essential tremor (a type of shaking), and dystonia (muscle contractions).

What does 'observational study' mean?

It means doctors will simply watch and record how you get on with your DBS system as part of your normal medical care. You won't be asked to do anything extra or try new treatments specifically for the study.

How long will the study follow me?

If you join, the study will follow your progress and how you're doing with your DBS system for up to 5 years after your first DBS programming visit.

Will this study give me new treatment?

No, this study is about observing the long-term effects of the Abbott DBS system you receive as part of your regular treatment, not about trying new treatments.

How to find out more

Claudia Salazar, PhD

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

Always speak to your GP or specialist before deciding to take part in a study.