Patient Research
Sign in
All studies
RecruitingNAINTERVENTIONAL

CANadian Adaptive DBS TriAl

This study is called the CANadian Adaptive DBS TriAl, or "CAN-ADAPT" for short. It's for people with Parkinson's disease who are already using deep brain stimulation (DBS) and need to replace their battery. Researchers want to compare two types of DBS: the standard kind (continuous DBS) and a newer, 'smarter' kind (adaptive DBS). Adaptive DBS can automatically adjust its settings based on how your body is responding. The study aims to find out if this adaptive DBS is better at treating issues like walking problems, balance, and speech difficulties, which can sometimes be hard to manage with standard treatment. It's a pilot study, meaning it's one of the first to look closely at this new approach.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Toronto
Enrolment target
10
Start
01 Jun 2024
Estimated completion
01 Dec 2025
Parkinson Disease

What is this study about?

When people have Parkinson's disease, symptoms like freezing when they walk or having quiet speech can really affect their daily lives. Sometimes, even with deep brain stimulation (DBS), these problems don't get much better, or can even get worse.

Deep brain stimulation usually provides a continuous, steady electrical pulse. But your body's needs can change quickly throughout the day. This study is exploring a new type of DBS called 'adaptive DBS' (aDBS) that's designed to be much smarter. It uses tiny signals from the brain itself to figure out when and how to adjust the stimulation. Think of it like a smart thermostat that adjusts the heating based on the room temperature, rather than just running continuously.

The main goal of this study is to see if this adaptive DBS can help with movement problems like freezing of gait (when your feet feel stuck) and balance issues, as well as speech difficulties. Researchers want to compare it to the standard, continuous DBS. They believe adaptive DBS might be better at tackling these specific problems because it can respond to your body's real-time signals. This is a pilot study, which means it's an early step in understanding if this new technology works well.

Key takeaways

  • This study compares a 'smart' adaptive DBS with standard continuous DBS for Parkinson's.
  • It targets specific symptoms like walking problems, balance, and speech issues.
  • You must have existing Medtronic DBS and need a battery replacement to participate.
  • The new adaptive DBS works by automatically adjusting to your brain's signals.
  • The study aims to see if adaptive DBS can offer better symptom control.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to have Parkinson's disease and already be receiving deep brain stimulation (DBS) using Medtronic leads. A key requirement is that you need to be due for a replacement of your DBS battery, known as the implantable pulse generator (IPG).

Doctors will also be looking for people who experience noticeable walking, balance, or speech problems that bother them, and importantly, these problems seem to get better when your DBS is temporarily turned off. You should be between 18 and 80 years old. You also need to be well enough to take part and understand what the study involves, and importantly, give your consent.

Some reasons you might not be able to join include having had DBS surgery with different equipment than Medtronic, or if you have other serious health problems (like severe depression or memory issues) that could make it difficult to take part or affect the study's results. If your doctor believes certain stimulation settings needed for the study wouldn't be safe or effective for you, that would also exclude you.

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.

  1. Do you have Parkinson's disease and already use deep brain stimulation (DBS) with Medtronic equipment?
  2. Are you due to have your DBS battery replaced soon?
  3. Do you regularly experience noticeable problems with walking, balance, or speech?
  4. Do these walking, balance, or speech problems tend to get better when your DBS is switched off?
  5. Are you between 18 and 80 years old?
  6. Are you able to understand the study information and agree to take part?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll have your current DBS battery replaced with a new device that can deliver both standard and adaptive stimulation. After this, you'll go through different phases where the researchers will compare how the adaptive DBS works against the continuous (standard) DBS. You won't know which type of stimulation you're receiving at any given time, and neither will the study team in some parts of the study. This is called 'double-blinded' and helps ensure the results are accurate. You'll have regular follow-up visits where assessments will be done to check your movement, speech, and overall well-being. The study will last for a period of time, which the study team will explain in detail, and your current medications for Parkinson's disease will be carefully monitored throughout. More information on specific visit schedules and assessments will be provided if you are eligible and interested.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the adaptive DBS might offer better control over specific Parkinson's symptoms like walking or speech issues than your current continuous DBS. It could also lead to a more personalised approach to your treatment in the future. However, there are also risks, like those normally associated with any battery replacement surgery. There's also the chance the new adaptive stimulation might not work better for you, or could even temporarily cause different side effects. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Movement Disorders Centre - Toronto Western Hospital
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is adaptive DBS?

Adaptive DBS is a 'smarter' type of deep brain stimulation that can automatically adjust its settings based on signals it reads from your brain, rather than staying on a fixed setting all the time.

What does 'double-blinded' mean?

It means that during the study, neither you nor the doctors assessing you will know whether you are receiving the adaptive DBS or the standard continuous DBS. This helps to make sure the results are fair and unbiased.

Will my regular Parkinson's medicines change?

Your regular Parkinson's medications will be carefully looked at and managed by the study team, but the study primarily focuses on the DBS settings.

What if I don't like the new stimulation?

If you feel unwell or have concerns, you should tell the study team immediately. You have the right to withdraw from the study at any time.

Why are they studying this?

Researchers are hoping adaptive DBS could offer a more tailored and effective way to manage some difficult Parkinson's symptoms like walking problems, balance, and speech difficulties.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "CANadian Adaptive DBS TriAl…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.