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Funding from The Parkinson Alliance helped to finance the following Parkinson's research. Grantees were selected by scientific review committees of participating organizations. Updates will be posted, when available.
Project Title: Freezing of Gait Device
Principal Investigator: Dr. Lily Laiho, Ph.D., Biomedical & General Engineering, California Polytechnic State University
Objective/Rationale: Freezing of Gait (FOG) is one of the most insidious symptoms of Parkinson’s Disease (PD). While PD was identified almost 200 years ago, a majority of the research appears to be centered on research for drugs, slowing the progression of the disease, or dyskinesia (tremors) and very little on FOG. Current therapies used to aid with FOG include music therapy, metronomes to set a pace for walking, and visualizing a target. We are proposing to design a device that can incorporate multiple therapies into a single device that can be used with a cane or walker to aid with FOG.
Project Description/Methods/Design: The main goal of this project is to create a reliable and cost-effective device that can assist individuals with Parkinson’s Disease in decreasing instances of freezing when FOG occurs. This device would provide an option of visual and/or auditory cues to help decrease freezing. A team of students and the PI will follow a structured design process to design, manufacture, and test this device. We will be working with a local PD support group through all phases of this study. We will create customer requirements and specifications for the final product to meet. We will then generate conceptual designs and develop many potential solutions. Using a structured decision process, we will select our final design and create a detailed design of the device, including machine and assembly drawings. We will then manufacture a prototype, test it, and use the results to improve upon our design and create our final prototype.
Relevance to Treatment of Parkinson’s Disease: With over 1 million people suffering from Parkinson’s Disease, assistive technology devices can be beneficial in overcoming some of the difficulties associated with the disease in everyday life, such as freezing of gait. We are proposing to create a device that could help people living with PD overcome instances of freezing of gait. This device could enable people to continue to walk when they experience a FOG event by incorporating several different compensatory strategies into a single device. This could help individuals with PD continue to walk for longer and subsequently help improve their quality of life.
Expected Outcome: From our work, we expect to create a prototype device that has the potential to assist individuals dealing with Freezing of Gait. Indicators of the success of this project will be determined by feedback from a local PD support group. We expect that the users of this device will be able to minimize their incidents of freezing. While the disabilities and discomforts associated with symptoms of PD will continue, we believe this device will enable its user to cope with difficulties from FOG, increase mobility, and improve their quality of life.
September 2015 Project Update:
Integrated Gait Solutions is a Cal Poly born mobility device design team. Two of our prototypes are effectively alleviating Freezing of Gait for a local member of the Central Coast Parkinson Support Group. The team is currently working to create improved prototypes, conduct more user trials, and of course to get the word out. Their mission is to ease the freeze.
Objective: Levodopa-resistant posture, gait, and freezing symptoms are among the most disabling and difficult to treat in persons with Parkinson’s disease (PD). Recent findings from randomized DBS clinical trials have been promising for addressing many aspects of PD, but have failed to definitively and consistently identify a therapeutic benefit for “on-medication” freezing and/or falling. Several attempts have been made to alleviate “on-medication” freezing through the use of human PPN and PPN+STN deep brain stimulation (DBS), all with mixed and inconclusive results. In our proposal we aim to uncover the critical science underpinning changes in the circuitry between the brain regions of GPi and PPN in awake behaving humans performing walking tasks.
Background: We believe there are two critical brain areas which are not functioning in concert in PD and that their dysfunction may lead to freezing of gait. We posit that we can develop a “smart” DBS system which will monitor these two brain areas (and the network between them), and deliver the pulses necessary to address freezing episodes in real time.
Methods/Design: We will simultaneously implant bilateral GPi and bilateral PPN DBS leads in 5 PD patients (with freezing while on medication). We will connect the DBS leads to a new technology (Medtronic PC+S) and monitor the real-time physiology of the brain network during walking and freezing. We will also utilize a novel technology to provide a rapid, automated closed-loop approach to break freezing episodes.
Relevance to Diagnosis/Treatment of Parkinson’s Disease: We have chosen the troublesome and clinically relevant symptom of on-medication freezing of gait (on-FoG), which currently has no optimal treatment option beyond assistive devices and cueing. This symptom is troublesome to many PD patients and this symptom can be levodopa and conventional DBS therapy resistant.
The neuromodulatory approach in this application will provide an immediately deployable solution for medication-refractory FoG, and results from this grant can possibly be moved into a larger clinical trial. This study will provide a significant enhancement of our understanding of the basic circuitry underlying gait issues and freezing in PD.
September 2015 Project Update:
To date, we have screened five patient candidates for the study. Two out of the five did not qualify as they did not exhibit five or more FoG episodes during the provocation protocol of our on or off medication state. Three of the five patients qualified and consented for the DBS surgery. Our first subject has undergone all three surgeries (i. placement of left leads, ii. placement of right leads, iii. implantation of neurostimulators), and the first month of post-implantation recordings. Our second patient will undergo the third surgery the second week of September, having completed the first two surgeries. Our third patient underwent the first surgery.
Results: Currently, we are analyzing our one month recordings from the first patient. The patient performed baseline recordings during standing, as well as step-in-place, walking and turning tasks. Each of the tasks induced five or more freezing episodes. We captured behavior through Vicon motion capture cameras, wearable EMG and acceleration sensors, and video cameras. A movement disorder specialist will view and rate the videos for the timing of the freezes. Our analyses will include analyzing the Vicon data, which can guide us for our wearable sensor placement for future data recording sessions with this patient. We will also analyze the wearable sensor data to see if freezing episodes can be reliably detected using such technology. Finally, we are analyzing the neural data using two approaches. We are comparing baseline standing activity to the data during the tasks without freezing episodes. As data from the human GPi and PPN is very rare, we are motivated to study how local field potentials in these two areas modulate with locomotion. With the exact timing of the freezes, we will examine neural activity leading up to, during and after the freezing episode. The comparison will again be made against the standing baseline data.
September 2016 Project Update:
We have enrolled and implanted all 5 subjects and the study is closed to enrollment. Each subject had 4 DBS leads placed (bilaterally in the GPi and bilaterally in the PPN). The operations to place the leads occurred over several days (staged). The DBS leads and batteries offer real-time physiological monitoring of different aspects of standing, walking, and freezing. We are analyzing data on each subject to better understand the brain waves associated with each condition and we are using this information to construct a smart DBS approach to freezing of gait. Results of the study should be available in 2017.- See more at: http://www.unitywalk.org/grants-archive.php?ID=531#sthash.hMc9JmVN.dpuf
September 2016 Project Update:
We have enrolled and implanted all 5 subjects and the study is closed to enrollment. Each subject had 4 DBS leads placed (bilaterally in the GPi and bilaterally in the PPN). The operations to place the leads occurred over several days (staged). The DBS leads and batteries offer real-time physiological monitoring of different aspects of standing, walking, and freezing. We are analyzing data on each subject to better understand the brain waves associated with each condition and we are using this information to construct a smart DBS approach to freezing of gait. Results of the study should be available in 2017.
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