Brain Stimulation for Freezing of Gait in Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people with Parkinson's disease who experience a specific walking problem called freezing of gait (FOG). Researchers seek to determine if a special kind of brain stimulation can improve walking by using brain-machine interfaces to better understand and treat FOG. During a standard surgery, participants will have small sensors placed on their brain to track and potentially adjust brain activity. This trial suits those with Parkinson's who struggle with FOG despite medication and are planning to undergo deep brain stimulation surgery. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that may lead to new treatments for FOG.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions studying gait both with and without medication, so you might be asked to adjust your medication use during the study.
What prior data suggests that this brain stimulation method is safe for treating freezing of gait in Parkinson's disease?
Research has shown that using electrocorticography (ECoG) to study brain activity in Parkinson's disease is generally safe for patients. One study recorded ECoG alongside other tests, such as walking assessments, and found no major safety issues. Another study used ECoG to monitor brain patterns related to movement, placing ECoG grids on patients' brains, and again reported no significant negative effects. These findings suggest that ECoG is usually safe for patients. While ECoG helps gather important information, current evidence indicates that the procedure is well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about brain stimulation for freezing of gait in Parkinson's Disease because it involves a novel approach using ECoG arrays. Unlike standard treatments like medication or traditional deep brain stimulation (DBS) that focus on altering brain activity broadly, ECoG implantation offers high-density recordings that allow for more precise targeting of the brain areas involved in gait control. This precision could potentially lead to better management of symptoms with fewer side effects. By directly addressing the neural patterns associated with freezing of gait, this method has the potential to provide more effective relief for patients.
What evidence suggests that brain stimulation might be an effective treatment for freezing of gait in Parkinson's disease?
Research has shown that brain stimulation can help treat some symptoms of Parkinson's disease, such as freezing of gait (FOG), where a person temporarily feels stuck and cannot move. In this trial, participants will undergo ECoG implantation as part of their brain stimulation treatment. Studies have found that adaptive deep brain stimulation (aDBS) can improve movement issues like slow movement and stiffness. Specifically, one study discovered that brain stimulation significantly reduced freezing episodes in patients. Overall, brain stimulation appears promising for addressing walking problems in Parkinson's disease, although results can vary among individuals.678910
Are You a Good Fit for This Trial?
This trial is for Parkinson's Disease patients who have severe freezing of gait (FOG) that doesn't fully improve with medication. They must meet the criteria for deep brain stimulation surgery, experience FOG during their 'on' medication phase, and be able to follow the study rules.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
ECoG Implantation
Patients will be implanted with high-density cortical ECoG arrays during DBS surgery
BMI Training and Experimentation
Participants will be trained to guide virtual effectors using the implanted BMI and explore BMI control to trigger and study FOG
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brain Stimulation
Trial Overview
The study tests a high-density electrocorticography-based brain-machine interface (BMI). It records and stimulates brain activity in real-world walking and FOG scenarios. The goal is to find patterns linked to FOG using machine learning and see if cortical stimulation can stop it.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will be implanted with high-density cortical ECoG arrays during DBS surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Toronto
Lead Sponsor
Citations
Could adaptive deep brain stimulation treat freezing of gait ...
Already promising results using aDBS have been achieved for symptoms such as bradykinesia, rigidity and motor fluctuations.
Long-term effect of subthalamic nucleus deep brain ...
Subthalamic nucleus deep brain stimulation (STN DBS) is effective against freezing of gait (FOG) in Parkinson's disease (PD); however, whether this effect ...
Effects of non-invasive brain stimulation on freezing of gait ...
Seven studies including 102 participants were included in the final analysis. The meta-analysis showed a significant improvement in freezing of gait ...
Beta burst-driven adaptive deep brain stimulation for gait ...
Gait metrics such as overall percent time freezing and mean peak shank angular velocity improved on adaptive deep brain stimulation compared to OFF and showed ...
Deep brain stimulation of symptom-specific networks in ...
Deep Brain Stimulation can improve tremor, bradykinesia, rigidity, and axial symptoms in patients with Parkinson's disease.
Synchronized Intracranial Electrical Activity and Gait ...
In this study, we established and verified the synchronized ECoG/LFP and gait recording system in PD patients with FOG.
Subthalamic nucleus stimulation at high and low ...
Following electrode implantation, patients underwent ECoG recordings, gait assessments and fMRI scans prior to their first clinical programming ...
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researchgate.net
researchgate.net/publication/320255864_Electrocorticographic_Encoding_of_Human_Gait_in_the_Leg_Primary_Motor_CortexElectrocorticographic Encoding of Human Gait in the Leg ...
Our preliminary results with subjects implanted with ECoG grids show distinct patterns of walking-induced activity over the leg motor cortex ...
Invasive neurophysiology and whole brain connectomics ...
Here, we evaluate electrocorticography (ECoG)-based movement decoding as a two-class classification problem (rest versus movement present) ...
EEG-Based Classification of Parkinson's Disease With ...
Freezing of gait (FOG) is a debilitating motor symptom of Parkinson's disease (PD) that significantly affects patient mobility and quality of life.
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