Deep Brain Stimulation for Parkinson's Disease (CANADA Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Toronto
No Placebo Group
Trial Summary
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.
Is Adaptive DBS a promising treatment for Parkinson's Disease?Yes, Adaptive DBS is a promising treatment for Parkinson's Disease. It can reduce side effects and improve battery life by adjusting stimulation based on the patient's needs. It also improves treatment effectiveness by automatically adapting to changes in the patient's condition, leading to better control of symptoms and reduced power consumption compared to traditional methods.12568
What data supports the idea that Deep Brain Stimulation for Parkinson's Disease is an effective treatment?The available research shows that Adaptive Deep Brain Stimulation (aDBS) is effective for treating Parkinson's Disease. It improves motor function scores compared to traditional DBS, as seen in the Unified Parkinson's Disease Rating Scale (UPDRS) assessments. aDBS also reduces side effects and extends battery life by adjusting stimulation based on real-time feedback from brain signals. This makes it potentially more effective than continuous DBS, which doesn't adapt to changes in the patient's condition.23456
What safety data is available for adaptive deep brain stimulation in Parkinson's disease?Adaptive deep brain stimulation (aDBS) has been shown to reduce side effects associated with continuous stimulation and improve motor symptoms in Parkinson's disease. Studies indicate that aDBS is effective and safe, with lower Unified Parkinson's Disease Rating Scale (UPDRS) scores and reduced electrical energy delivered compared to conventional DBS. Ongoing research, including multicenter trials, is assessing the long-term safety and efficacy of aDBS using new implantable pulse generators.34679
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the focus is on deep brain stimulation, it's best to discuss your current medications with the study team.
Eligibility Criteria
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous DBSExperimental Treatment1 Intervention
Group II: Adaptive DBSActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Movement Disorders Centre - Toronto Western HospitalToronto, Canada
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Who is running the clinical trial?
University of TorontoLead Sponsor
References
Adaptive deep brain stimulation (aDBS) controlled by local field potential oscillations. [2013]Despite their proven efficacy in treating neurological disorders, especially Parkinson's disease, deep brain stimulation (DBS) systems could be further optimized to maximize treatment benefits. In particular, because current open-loop DBS strategies based on fixed stimulation settings leave the typical parkinsonian motor fluctuations and rapid symptom variations partly uncontrolled, research has for several years focused on developing novel "closed-loop" or "adaptive" DBS (aDBS) systems. aDBS consists of a simple closed-loop model designed to measure and analyze a control variable reflecting the patient's clinical condition to elaborate new stimulation settings and send them to an "intelligent" implanted stimulator. The major problem in developing an aDBS system is choosing the ideal control variable for feedback. Here we review current evidence on the advantages of neurosignal-controlled aDBS that uses local field potentials (LFPs) as a control variable, and describe the technology already available to create new aDBS systems, and the potential benefits of aDBS for patients with Parkinson's disease.
Controlling Parkinson's disease with adaptive deep brain stimulation. [2022]Adaptive deep brain stimulation (aDBS) has the potential to improve the treatment of Parkinson's disease by optimizing stimulation in real time according to fluctuating disease and medication state. In the present realization of adaptive DBS we record and stimulate from the DBS electrodes implanted in the subthalamic nucleus of patients with Parkinson's disease in the early post-operative period. Local field potentials are analogue filtered between 3 and 47 Hz before being passed to a data acquisition unit where they are digitally filtered again around the patient specific beta peak, rectified and smoothed to give an online reading of the beta amplitude. A threshold for beta amplitude is set heuristically, which, if crossed, passes a trigger signal to the stimulator. The stimulator then ramps up stimulation to a pre-determined clinically effective voltage over 250 msec and continues to stimulate until the beta amplitude again falls down below threshold. Stimulation continues in this manner with brief episodes of ramped DBS during periods of heightened beta power. Clinical efficacy is assessed after a minimum period of stabilization (5 min) through the unblinded and blinded video assessment of motor function using a selection of scores from the Unified Parkinson's Rating Scale (UPDRS). Recent work has demonstrated a reduction in power consumption with aDBS as well as an improvement in clinical scores compared to conventional DBS. Chronic aDBS could now be trialed in Parkinsonism.
Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. [2022]Adaptive deep brain stimulation (aDBS) uses feedback from brain signals to guide stimulation. A recent acute trial of unilateral aDBS showed that aDBS can lead to substantial improvements in contralateral hemibody Unified Parkinson's Disease Rating Scale (UPDRS) motor scores and may be superior to conventional continuous DBS in Parkinson's disease (PD). We test whether potential benefits are retained with bilateral aDBS and in the face of concurrent medication.
The adaptive deep brain stimulation challenge. [2018]Sub-optimal clinical outcomes of conventional deep brain stimulation (cDBS) in treating Parkinson's Disease (PD) have boosted the development of new solutions to improve DBS therapy. Adaptive DBS (aDBS), consisting of closed-loop, real-time changing of stimulation parameters according to the patient's clinical state, promises to achieve this goal and is attracting increasing interest in overcoming all of the challenges posed by its development and adoption. In the design, implementation, and application of aDBS, the choice of the control variable and of the control algorithm represents the core challenge. The proposed approaches, in fact, differ in the choice of the control variable and control policy, in the system design and its technological limits, in the patient's target symptom, and in the surgical procedure needed. Here, we review the current proposals for aDBS systems, focusing on the choice of the control variable and its advantages and drawbacks, thus providing a general overview of the possible pathways for the clinical translation of aDBS with its benefits, limitations and unsolved issues.
Adaptive Deep Brain Stimulation for Movement Disorders: The Long Road to Clinical Therapy. [2022]Continuous high-frequency DBS is an established treatment for essential tremor and Parkinson's disease. Current developments focus on trying to widen the therapeutic window of DBS. Adaptive DBS (aDBS), where stimulation is dynamically controlled by feedback from biomarkers of pathological brain circuit activity, is one such development. Relevant biomarkers may be central, such as local field potential activity, or peripheral, such as inertial tremor data. Moreover, stimulation may be directed by the amplitude or the phase (timing) of the biomarker signal. In this review, we evaluate existing aDBS studies as proof-of-principle, discuss their limitations, most of which stem from their acute nature, and propose what is needed to take aDBS into a chronic setting. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.
Toward adaptive deep brain stimulation in Parkinson's disease: a review. [2019]Clinical deep brain stimulation (DBS) is now regarded as the therapeutic intervention of choice at the advanced stages of Parkinson's disease. However, some major challenges of DBS are stimulation induced side effects and limited pacemaker battery life. Side effects and shortening of pacemaker battery life are mainly as a result of continuous stimulation and poor stimulation focus. These drawbacks can be mitigated using adaptive DBS (aDBS) schemes. Side effects resulting from continuous stimulation can be reduced through adaptive control using closed-loop feedback, while those due to poor stimulation focus can be mitigated through spatial adaptation. Other advantages of aDBS include automatic, rather than manual, initial adjustment and programming, and long-term adjustments to maintain stimulation parameters with changes in patient's condition. Both result in improved efficacy. This review focuses on the major areas that are essential in driving technological advances for the various aDBS schemes. Their challenges, prospects and progress so far are analyzed. In addition, important advances and milestones in state-of-the-art aDBS schemes are highlighted - both for closed-loop adaption and spatial adaption. With perspectives and future potentials of DBS provided at the end.
Eight-hours conventional versus adaptive deep brain stimulation of the subthalamic nucleus in Parkinson's disease. [2022]This study compares the effects on motor symptoms between conventional deep brain stimulation (cDBS) and closed-loop adaptive deep brain stimulation (aDBS) in patients with Parkinson's Disease. The aDBS stimulation is controlled by the power in the beta band (12-35 Hz) of local field potentials recorded directly by subthalamic nucleus electrodes. Eight subjects were assessed in two 8-h stimulation sessions (first day, cDBS; second day, aDBS) with regular levodopa intake and during normal daily activities. The Unified Parkinson's Disease Rating Scale (UPDRS) part III scores, the Rush scale for dyskinesias, and the total electrical energy delivered to the tissues per second (TEEDs) were significantly lower in the aDBS session (relative UPDRS mean, cDBS: 0.46 ± 0.05, aDBS: 0.33 ± 0.04, p = 0.015; UPDRS part III rigidity subset mean, cDBS: 2.9143 ± 0.6551 and aDBS: 2.1429 ± 0.5010, p = 0.034; UPDRS part III standard deviation cDBS: 2.95, aDBS: 2.68; p = 0.047; Rush scale, cDBS 2.79 ± 0.39 versus aDBS 1.57 ± 0.23, p = 0.037; cDBS TEEDs mean: 28.75 ± 3.36 µj s-1, aDBS TEEDs mean: 16.47 ± 3.33, p = 0.032 Wilcoxon's sign rank test). This work further supports the safety and effectiveness of aDBS stimulation compared to cDBS in a daily session, both in terms of motor performance and TEED to the patient.
Deep brain stimulation: is it time to change gears by closing the loop? [2022]Objective.Adaptive deep brain stimulation (aDBS) is a form of invasive stimulation that was conceived to overcome the technical limitations of traditional DBS, which delivers continuous stimulation of the target structure without considering patients' symptoms or status in real-time. Instead, aDBS delivers on-demand, contingency-based stimulation. So far, aDBS has been tested in several neurological conditions, and will be soon extensively studied to translate it into clinical practice. However, an exhaustive description of technical aspects is still missing.Approach.in this topical review, we summarize the knowledge about the current (and future) aDBS approach and control algorithms to deliver the stimulation, as reference for a deeper undestending of aDBS model.Main results.We discuss the conceptual and functional model of aDBS, which is based on the sensing module (that assesses the feedback variable), the control module (which interpretes the variable and elaborates the new stimulation parameters), and the stimulation module (that controls the delivery of stimulation), considering both the historical perspective and the state-of-the-art of available biomarkers.Significance.aDBS modulates neuronal circuits based on clinically relevant biofeedback signals in real-time. First developed in the mid-2000s, many groups have worked on improving closed-loop DBS technology. The field is now at a point in conducting large-scale randomized clinical trials to translate aDBS into clinical practice. As we move towards implanting brain-computer interfaces in patients, it will be important to understand the technical aspects of aDBS.
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]After several years of brain-sensing technology development and proof-of-concept studies, adaptive deep brain stimulation (aDBS) is ready to better treat Parkinson's disease (PD) using aDBS-capable implantable pulse generators (IPGs). New aDBS devices are capable of continuous sensing of neuronal activity from the subthalamic nucleus (STN) and contemporaneous stimulation automatically adapted to match the patient's clinical state estimated from the analysis of STN activity using proprietary algorithms. Specific studies are necessary to assess superiority of aDBS vs conventional DBS (cDBS) therapy. This protocol describes an original innovative multicentre international study aimed to assess safety and efficacy of aDBS vs cDBS using a new generation of DBS IPG in PD (AlphaDBS system by Newronika SpA, Milan, Italy).