At present, there is no cure for Parkinson's disease. The standard treatment involves taking dopaminergic drugs. When drugs lose their effectiveness, they can be supplemented by Deep Brain Stimulation (DBS) therapy. Medication and deep brain stimulation are effective for motor problems such as tremors, slowness of movement, and muscle stiffness. However, there is no effective treatment for walking and balance problems that occur during the course of the disease. DBS neurostimulators not only stimulate, but also record brain activity in the region in which the electrodes are implanted. This brain activity changes over time, depending on the individual's general state (i.e., medication, eating), movements (sitting, standing or walking) and motor problems (i.e., problems of gait initiation and termination, balance problems and freezing of gait). Adaptive deep brain stimulation (aDBS) makes it possible to change the stimulation according to brain activity, and thus to these different states. This method involves using the usual Medtronic Percept neurostimulator with its adaptive therapy active. Additional investigational features for adaptive therapy are available within the study. In this study, we want to evaluate whether adaptive deep brain stimulation is safe and effective in improving walking problems in people with Parkinson's disease.
The hypotheses of the current study are that: HYPOTHESIS 1: Adaptive DBS, aligned in time to the occurrence of locomotor states, facilitates gait initiation, termination, turning, symmetry and adaptations to obstacles by titrating the delivery of stimulation to the dynamics of gait. HYPOTHESIS 2: Enforcing that biomarkers of FoG never exceed an abnormally-high value prevents the occurrence of freezing of gait. The resulting observations will establish a rigorous understanding of motor state-dependent DBS modulations that will open new avenues for the design of evidence-based DBS strategies for locomotor deficits. The study is divided into 3 different phases, which will take place on 3 different days at CHUV, and will be spread over a maximum of 5 weeks: PHASE 1: Eligibility (1 day at CHUV) * Evaluate Feasibility for aDBS * Characterize DBS and Movement Modulations * Assess Global Parkinsonian State PHASE 2: aDBS therapy setup and efficacy evaluation in different conditions (between 2 to 3 days at CHUV) * Optimize aDBS Parameters * Test Safety and Performance * Evaluate Stability and Robustness * Daily Life Use of aDBS The 2 to 3 days of Phase 2 will happenoccur within 10 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Adapting DBS stimulation based on locomotor states to alleviate gait deficits
CHUV
Lausanne, Canton of Vaud, Switzerland
RECRUITINGAdverse events
Occurrence of adverse events and serious adverse events that are deemed related or possibly related to the study procedures, or the use of the investigational system during the duration of the study
Time frame: Through study completion, a maximum of 5 weeks
Gait performance
Timed up-and-go (TUG) task and 10m walk test are tests used to test used to assess gait speed and sit ro stand and gait ability. In the TUG cognitive the participant is also asked to perform a cognitive task when performing the motor task to see the gait ability during dual-task.
Time frame: At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.
Freezing of Gait occurances
\- The 360° turn test is used to assess freezing during turn. It measures the time it takes to make a full turn on oneself and the number of steps. • A custom-made freezing of gait (FOG) circuit is designed to assess the occurrence of freezing of gait. Participants are asked to perform tasks known to favour freezing of gait occurrence. Participants can use their habitual assistive device and perform the task at comfortable speed.
Time frame: At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.
Global Parkinsonian State
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scale will be performed to evaluate the general motor state of the participant.18 items, score range: 0 (mild) - 132 (severe)
Time frame: At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.
Changes in neural patterns
Evaluation of changes in neural patterns in response to adaptive protocols that are aligned in time to biomarkers of locomotor states / transitions. Measured variables: Changes in neural signals recorded with the implantable system across all the aforementioned locomotor tasks.
Time frame: At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.
Sustained efficacy of adaptive DBS during activities of daily life - kinematics parameters
Out-of-the-lab kinematic monitoring is used to evaluate the evolution of the gait pattern in an ecological environment. Participants will be asked to wear a pair of Nushu X sensorized shoes (Magnes AG, Swizterland - CE-marked as electronic device) with integrated motion feedback sensors during the phase 3 of the study, at CHUV. To monitor the rest of the body kinematics, sensors (Physilog, Mindmaze, Switzerland) will be placed on both wrists of the participants.
Time frame: At Phase 2, during the last day of the study (2nd or 3rd day of Phase 2 within a maximum of 5 weeks from Day1 of Phase 1).
Sustained efficacy of adaptive DBS during activities of daily life - questionnaire
Evaluation of aDBS in activities of daily living questionnaire is a self-administered questionnaire designed within the scope of this study. It will evaluate the perceived gait quality, and overall motor performance with aDBS during the day
Time frame: At Phase 2, during the last day of the study (2nd or 3rd day of Phase 2 within a maximum of 5 weeks from Day1 of Phase 1).
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