Deep Brain Stimulation for Parkinson's Disease

(CANADA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Previous DBS without Medtronic, Medically unstable, Severe non-motor problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of deep brain stimulation (DBS) for individuals with Parkinson's disease who experience difficulties with walking or speaking. Researchers aim to determine if adaptive DBS, which adjusts automatically based on the patient's condition, improves these symptoms more effectively than continuous DBS, which remains constant. Eligible participants should have Parkinson's disease, currently use a specific DBS system, and experience worsening issues with walking, balance, or speech despite their current DBS. As an unphased trial, this study allows participants to contribute to cutting-edge research that could enhance treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that this novel implantable DBS system is safe for Parkinson's Disease patients?

Studies have shown that both adaptive and continuous deep brain stimulation (DBS) are generally safe for people with Parkinson's disease. Research indicates that adaptive DBS is not only safe but also well-tolerated over time. Patients have reported feeling better overall, and the treatment has been effective for those with stable symptoms.

Continuous DBS has a strong history of safety, with studies showing it remains safe even after five years of use. It effectively manages Parkinson's motor symptoms, providing lasting relief. Specialized centers have tested both adaptive and continuous DBS, supporting their safety and effectiveness.

Overall, both treatments are considered safe, and previous patients have handled them well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to manage Parkinson's Disease symptoms. Unlike standard Deep Brain Stimulation (DBS), which delivers continuous electrical pulses to the brain, Adaptive DBS adjusts its stimulation in real-time based on the patient's brain activity. This personalized approach aims to improve symptom control and reduce side effects. Continuous DBS, while not new, serves as a useful comparison to explore the benefits of adaptive techniques. By investigating these methods, researchers hope to find more effective and tailored treatments for people with Parkinson's Disease.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

This trial will compare Adaptive Deep Brain Stimulation (aDBS) with Continuous Deep Brain Stimulation (cDBS) for Parkinson's disease. Research has shown that aDBS can greatly improve movement in people with Parkinson's disease. One study found a 33.9% improvement in movement, and aDBS uses less energy than cDBS. Patients using aDBS also experienced more "on" time, meaning fewer troublesome movements. Meanwhile, Continuous DBS has significantly improved movement and daily activities for up to five years. Both treatments are effective, but aDBS may offer more precise adjustments based on individual needs, potentially aiding speech and walking problems. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients with specific disabling gait, balance, or speech issues worsened by their current DBS treatment. Participants must need an IPG replacement, have a good LFP signal for adaptive DBS use, and be able to consent and follow the study plan. Those with severe non-motor problems like depression or dementia, unstable medical conditions, non-Medtronic DBS systems, or other disorders affecting outcomes can't join.

Inclusion Criteria

I'm sorry, but this criterion seems to be incomplete or unclear. It's difficult to provide a plain and simple explanation without more context or details. If you can provide more information or clarify the criterion, I'd be happy to help.

You need to replace the device that sends electrical pulses to your body because the battery is running out of power.

Your walking, balance, or speech problems get worse when the deep brain stimulation (DBS) is turned on, and get better when it's turned off.

Exclusion Criteria

You have severe mental health issues like depression or dementia.

You are using a specific type of electrical stimulation that would interfere with the study treatment.

Medically unstable

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive continuous DBS (cDBS) or adaptive DBS (aDBS) in a cross-over design

2-5 months

Regular visits for monitoring and adjustments

Treatment Phase 2

Participants switch to the alternate DBS method (aDBS or cDBS) in the cross-over design

3 months

Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

Follow-up visits at 5 and 8 months after battery change

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive DBS
• Continuous DBS

Trial Overview The CANadian Adaptive DBS Trial is testing a new 'adaptive' deep brain stimulation (aDBS) against the standard continuous DBS (cDBS). It aims to see if aDBS can better improve speech and walking issues in Parkinson's patients by adjusting stimulation based on real-time brain signals.

How Is the Trial Designed?

Group I: Continuous DBS Experimental Treatment 1 Intervention

Group II: Adaptive DBS Active Control 1 Intervention

Adaptive DBS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DBS Therapy for Parkinson's Disease for:

• Adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years' duration that are not adequately controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications of longer-standing duration

Approved in European Union as DBS Therapy for Parkinson's Disease for:

• Treatment of disabling motor symptoms of recent and longer-standing Parkinson's disease, essential tremor, and epilepsy

Approved in Canada as DBS Therapy for Parkinson's Disease for:

• Treatment of disabling motor symptoms of recent and longer-standing Parkinson's disease, essential tremor, and epilepsy

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Published Research Related to This Trial

Adaptive deep brain stimulation (aDBS) is a promising advancement in treating essential tremor and Parkinson's disease, as it adjusts stimulation based on real-time feedback from brain activity or tremor data.

Current studies on aDBS show proof-of-principle but are limited by their short duration; further research is needed to implement aDBS effectively in long-term treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive Deep Brain Stimulation for Movement Disorders: The Long Road to Clinical Therapy. Meidahl, AC., Tinkhauser, G., Herz, DM., et al.[2022]

Adaptive deep brain stimulation (aDBS) offers a more responsive treatment for neurological conditions by delivering stimulation based on real-time patient feedback, unlike traditional continuous stimulation methods.

The aDBS system consists of three key components: a sensing module to assess patient status, a control module to interpret this data, and a stimulation module to deliver targeted therapy, paving the way for future large-scale clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation: is it time to change gears by closing the loop? Marceglia, S., Guidetti, M., Harmsen, IE., et al.[2022]

Adaptive deep brain stimulation (aDBS) can significantly reduce side effects and prolong pacemaker battery life in patients with advanced Parkinson's disease by using closed-loop feedback and spatial adaptation techniques.

aDBS offers improved efficacy through automatic adjustments to stimulation parameters, allowing for better management of the patient's condition over time, which is a major advancement over traditional continuous stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward adaptive deep brain stimulation in Parkinson's disease: a review. Mohammed, A., Bayford, R., Demosthenous, A.[2019]

Adaptive deep brain stimulation (aDBS) shows promise in improving Parkinson's disease treatment by adjusting stimulation in real-time based on the patient's brain activity, specifically targeting beta amplitude fluctuations.

In early trials, aDBS demonstrated reduced power consumption and improved motor function scores compared to traditional deep brain stimulation, suggesting it could be a more efficient and effective long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling Parkinson's disease with adaptive deep brain stimulation. Little, S., Pogosyan, A., Neal, S., et al.[2022]

Deep brain stimulation (DBS) is effective for treating neurological disorders like Parkinson's disease, but traditional open-loop systems may not fully control motor fluctuations and rapid symptom changes.

Adaptive DBS (aDBS) systems, which use local field potentials (LFPs) as a feedback control variable, show promise in optimizing stimulation settings in real-time, potentially improving treatment outcomes for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive deep brain stimulation (aDBS) controlled by local field potential oscillations. Priori, A., Foffani, G., Rossi, L., et al.[2013]

The study aims to evaluate the safety and efficacy of adaptive deep brain stimulation (aDBS) compared to conventional deep brain stimulation (cDBS) in treating Parkinson's disease, involving 15 patients with existing DBS systems across six sites in Italy, Poland, and the Netherlands.

The trial will assess both short-term (2 days in a hospital setting) and long-term (1 month at home) outcomes, focusing on the tolerability of the new AlphaDBS system and its potential advantages in adapting stimulation based on real-time neuronal activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind cross-over pilot trial protocol to evaluate the safety and preliminary efficacy of long-term adaptive deep brain stimulation in patients with Parkinson's disease. Marceglia, S., Conti, C., Svanidze, O., et al.[2022]

Bilateral adaptive deep brain stimulation (aDBS) significantly improved motor symptoms in Parkinson's disease patients, with a 43% reduction in Unified Parkinson's Disease Rating Scale (UPDRS) scores compared to no stimulation, indicating its efficacy.

The improvements were achieved even with only 45% of the time on stimulation and while patients were concurrently taking levodopa, suggesting that aDBS can effectively adapt to the patient's needs and enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. Little, S., Beudel, M., Zrinzo, L., et al.[2022]

In a study involving 8 patients with Parkinson's Disease, closed-loop adaptive deep brain stimulation (aDBS) significantly improved motor symptoms compared to conventional deep brain stimulation (cDBS), as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).

aDBS not only resulted in lower UPDRS scores and reduced dyskinesias but also delivered less electrical energy to the brain, indicating a more efficient and potentially safer treatment option for managing motor symptoms in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-hours conventional versus adaptive deep brain stimulation of the subthalamic nucleus in Parkinson's disease. Bocci, T., Prenassi, M., Arlotti, M., et al.[2022]

Adaptive deep brain stimulation (aDBS) offers a promising advancement over conventional deep brain stimulation (cDBS) for treating Parkinson's Disease by allowing real-time adjustments to stimulation parameters based on the patient's clinical state.

The effectiveness of aDBS heavily relies on the selection of control variables and algorithms, which presents challenges in system design and implementation, highlighting the need for careful consideration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adaptive deep brain stimulation challenge. Arlotti, M., Rosa, M., Marceglia, S., et al.[2018]

Citations

1. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36471098/

Adaptive deep brain stimulation for Parkinson's disease Results: Quantitative analysis showed that aDBS, with a reduction of TEED (55% of that of cDBS), significantly improved motor functions (33.9%, ...

4. apdaparkinson.org apdaparkinson.org/article/adaptive-deep-brain-stimulation-dbs/

Adaptive DBS: A New Era in Parkinson's Disease Treatment Results showed that patients using adaptive DBS experienced significant improvements in “on” time without troublesome dyskinesias, needed lower ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357172/

Closed-Loop Adaptive Deep Brain Stimulation in ... Concerning PD, multiple clinical studies have demonstrated that DBS was more effective than best medical therapy for moderate-to-severe PD [9] ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40982287/

Long-Term Personalized Adaptive Deep Brain Stimulation ... Importance: Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation amplitude in response to changes in relevant neural ...