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 tests a new type of brain stimulation for Parkinson's patients that adjusts itself automatically based on brain activity. It aims to help those who have symptoms like freezing of gait or trouble speaking, which are not well-treated by current methods. This new approach has been shown to be at least as effective as traditional methods, with reduced stimulation time and fewer side effects.

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.

Is adaptive deep brain stimulation (aDBS) safe for humans?

Research suggests that adaptive deep brain stimulation (aDBS) is generally safe for humans, as it reduces side effects compared to conventional continuous DBS by using feedback from brain signals to adjust stimulation. Studies have shown that aDBS can lower the total electrical energy delivered to the brain, which may help in reducing side effects and prolonging the battery life of the device. ^{1 2 3 4 5}

How is adaptive deep brain stimulation (aDBS) different from other treatments for Parkinson's disease?

Adaptive deep brain stimulation (aDBS) is unique because it adjusts the stimulation in real-time based on the patient's brain activity, unlike traditional continuous DBS which provides constant stimulation. This on-demand approach helps reduce side effects and extends the battery life of the device by only stimulating when necessary, improving overall treatment effectiveness. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Adaptive Deep Brain Stimulation (aDBS) for Parkinson's Disease?

Research shows that aDBS can improve motor function in Parkinson's patients by adjusting stimulation based on brain signals, leading to better clinical scores and reduced power consumption compared to traditional continuous DBS. ^{3 4 5 6 8}

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) 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Adaptive Deep Brain Stimulation for Movement Disorders: The Long Road to Clinical Therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Controlling Parkinson's disease with adaptive deep brain stimulation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Toward adaptive deep brain stimulation in Parkinson's disease: a review. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The adaptive deep brain stimulation challenge. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Eight-hours conventional versus adaptive deep brain stimulation of the subthalamic nucleus in Parkinson's disease. [2022]

7. England 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Deep brain stimulation: is it time to change gears by closing the loop? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adaptive deep brain stimulation (aDBS) controlled by local field potential oscillations. [2013]