Active not recruitingNAINTERVENTIONAL

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

This research, called ROAM-DBS, is for people with Parkinson's disease who are already part of another study (ADROIT) and are having Deep Brain Stimulation (DBS) with an Abbott device. It wants to see if using a new 'Virtual Clinic' feature for adjusting DBS settings can help patients feel better sooner. Currently, these adjustments usually happen in person. The study will compare how quickly people improve when they only have in-person adjustments versus those who can have a mix of in-person and virtual adjustments over a smartphone or tablet. The goal is to see if the Virtual Clinic makes the adjustment process quicker and more convenient.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

100

Start

24 Mar 2022

Estimated completion

01 Dec 2024

Parkinson Disease

What is this study about?

You're probably here because you or someone you know is living with Parkinson's disease and possibly considering or already has Deep Brain Stimulation (DBS). DBS involves a small device placed in your body, similar to a pacemaker, which sends electrical signals to specific areas of the brain to help manage symptoms like tremors or stiffness. After the device is put in, it needs to be carefully adjusted, or 'programmed,' by a healthcare professional to find the best settings for you. This often involves several trips to the clinic.

This study, called ROAM-DBS, is testing a new way to do these adjustments. It uses a special feature called 'NeuroSphere Virtual Clinic' on some Abbott DBS systems. Imagine being able to talk to your doctor and have them make small adjustments to your DBS settings from your own home, using a secure app on a smartphone or tablet. This study wants to see if this 'Virtual Clinic' option can help people with Parkinson's get their DBS settings just right, and feel better, more quickly than with only in-person visits.

The main aim is to see if patients using this virtual option improve their symptoms faster. If successful, this could mean fewer trips to the hospital for programming, making treatment more convenient and possibly speeding up the process of finding the most effective DBS settings for each individual. It's about making your care more flexible and responsive to your needs.

Key takeaways

This study tests if remote DBS adjustments help Parkinson's patients improve faster.
It uses a 'Virtual Clinic' app for some DBS programming sessions.
Participation involves either in-clinic visits or a mix of virtual and in-clinic visits.
The study aims to see if less travel and quicker adjustments are possible.
You would need to be part of another study (ADROIT) to join.

Who may be eligible?

To join this study, you must already be taking part in another study called ADROIT. You need to be over 21 years old and able to read and write. You must be having an Abbott Infinity DBS system implanted for your Parkinson's disease, and you shouldn't have had a DBS system before.

Your doctor will also need to think that the 'Virtual Clinic' feature is a good idea for your treatment. You'll need to have access to this Virtual Clinic system through your hospital and have an internet connection at home that's good enough for virtual appointments with your doctor.

You wouldn't be able to join if you're already in another study that might affect these results, or if you have other health issues that would make it hard for you to take part or follow the study's instructions. If your DBS leads aren't placed correctly, or if you wouldn't be able to use the Virtual Clinic feature or explain your symptoms during a virtual visit, you also wouldn't be able to participate.

Quick self-check

Are you currently in the ADROIT study?
Are you 21 years old or older?
Are you about to have an Abbott Infinity DBS system for Parkinson's?
Do you have reliable internet access at home?
Can you comfortably use a smartphone or tablet for virtual appointments?
Has your doctor agreed that the Virtual Clinic is suitable for you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will compare two groups. One group will have their DBS settings adjusted only through visits to the clinic, as is currently standard. The other group will have the option to have some of their adjustments done via the new Virtual Clinic feature, which involves secure online sessions with your doctor from your home, as well as some clinic visits.

The main part of the study will follow you for 3 months to see how quickly your symptoms improve. After this, you'll continue to be followed for a full year for further assessments. You'll also continue to be part of the ADROIT study, completing its 6-month and 1-year check-ups. The doctors will be looking at how you feel and how your symptoms are changing throughout this time. The total time you'd be involved in the ROAM-DBS study itself is 1 year.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that if you're in the group using the Virtual Clinic, you might find that your DBS settings are optimised more quickly, potentially leading to faster symptom relief and fewer trips to the hospital. All participants will receive careful monitoring and support from their medical team. Potential risks are generally low, as the DBS system is already approved and used. However, as with any medical technology, there could be unforeseen issues or discomfort, and virtual consultations might feel different to in-person ones. You are free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (18)

University of Arizona Health Sciences Center
Tucson, United States
University of California at Davis
Sacramento, United States
University of Miami Hospital
Miami, United States
Rush University Medical Center
Chicago, United States
Indiana University
Indianapolis, United States
Beth Israel Deaconess Medical Center
Boston, United States
Dartmouth Hitchcock Medical Center
Lebanon, United States
The Cleveland Clinic Foundation
Cleveland, United States
Ohio State Medical
Columbus, United States
Thomas Jefferson Department of Neurosurgery
Philadelphia, United States
Texas Movement Disorder Specialist
Georgetown, United States
Universitäts Klinikum Tübingen
Tübingen, Germany

+6 more sites — see the official record for the full list.

Common questions

What is Deep Brain Stimulation (DBS)?

DBS is a treatment for Parkinson's disease where a small device is implanted to send electrical signals to the brain, helping to control symptoms like tremors.

What is the 'Virtual Clinic'?

The 'Virtual Clinic' is a new feature that allows your doctor to remotely adjust your DBS settings and check on your symptoms using a secure app on your smartphone or tablet, without you having to travel to the clinic.

Will I still have in-person appointments?

Yes, even if you are in the Virtual Clinic group, you will still have some in-person clinic visits. The Virtual Clinic option is designed to complement, not completely replace, your physical appointments.

How long will I be in the study?

You will be closely followed for 3 months for the main part of the study, and then for a full year for all the assessments. You will also continue your involvement with the ADROIT study.

Who is running this study?

This study is being conducted by Abbott, who make the DBS system, at several medical centres across North America and Europe.