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| Name | Class |
|---|---|
| ETH Zurich (Switzerland) | OTHER |
| Cereneo AG | INDUSTRY |
| University Children's Hospital, Zurich | OTHER |
| Lake Lucerne Institute AG |
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Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs.
Disability is largely driven by mobility deficits caused by impaired gait. Effective treatments are available to restore lower limb function and improve gait, but response to treatment varies greatly from patient to patient and often shows only small effect sizes. Addressing this heterogeneity requires personalization, a concept referred to precision neurorehabilitation.
StimuLOOP.PD intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigator will conduct a proof-of-concept study to investigate a combination of two methods that are each tailored to the individual patient. Two innovative technologies are applied in concert to enhance recovery of lower limb function.
The HPF intervention is expected to induce rapid adaptations, which however do not persist over multiple days. To counter this, the investigator will leverage memory reactivation during sleep to enhance the consolidation of the movement patterns that are learned during HPF.
The investigator expect that these interventions will lead to greater gains in functional walking ability. Beyond demonstrating a proof-of-concept for novel methods of precision neurorehabilitation, positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of HPF and TASS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptation Arm | Sham Comparator | Hyper-personalized feedback-based motor rehabilitation with sham targeted auditory stimulation during sleep (HPF intervention, TASS sham intervention) |
|
| Consolidation arm | Experimental | Hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS verum intervention) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyper-personalized feedback (HPF intervention) | Behavioral | For lower limb motor rehabilitation, the investigator will employ real-time continuous feedback for movement aspects that are specific to each participant's motor deficit. The feedback will be adapted and tailored to each participant. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 min walking test | Change in functional walking ability assessed with the 6 min walking test | Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation |
| MiniBEST test | the change in postural stability assessed with the MiniBEST test | Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Coordination Index | Motor learning assessed via changes in coordination. Coordination assessed using the Phase Coordination Index. | Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training |
| Continuous Relative Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Standard sleep architecture measures | Single-channel sleep Electroencephalography (EEG): (e.g. % N3, % N2, wake after sleep onset, Sleep efficiency) from scored EEG, electromyography (EMG), and electrooculography (EOG) signal (note: bandpass filtered EMG and EOG signal will only be used for offline sleep scoring according to American Academy of Sleep Medicine standards) | During 15 days of motor rehabilitation training |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| UNKNOWN |
Consolidation Arm: hyper-personalized feedback based-motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS intervention)
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Quadruple (participant, care provider, investigator, outcomes assessor).
|
| Targeted auditory stimulation during sleep (TASS verum intervention) | Behavioral | The investigator aim to reactivate rehabilitation- related memories through the presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands |
|
| Control targeted auditory stimulation during sleep (TASS sham intervention) | Behavioral | Identical auditory presentation during the motor rehabilitation training, but not during the night (sham promotion memory reactivation) |
|
Motor learning assessed via changes in coordination. Coordination assessed using Continous Relative Phase. |
| Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training |
| Variability | Motor learning assessed via changes in variability. Variability assessed using the coefficient of variation (%CV) of common spatio-temporal gait parameters, including stride time, stride length, step length, swing time, stance time, step width, and double limb support time. | Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training |
| Symmetry | Motor learning assessed via changes in symmetry. Symmetry (%) in step length and step time. | Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training |
| Margin of Stability | Motor learning assessed via changes in stability. Stability assessed using Margin of Stability. | Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training |
| Resilience | Motor learning assessed via changes in stability: Stability assessed using resilience metrics. | Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training |
| Event related spectral perturbation (ERSP) | ERSP: [µV^2/Hz or % or dB of baseline if normalized over time] and event-related potential (ERP) [µV over time] locked to stimuli from frontal, single-channel EEG signal | During 15 days of motor rehabilitation training |
| Frequency spectrum | Single-channel sleep EEG: [µV^2/Hz] from frontal, single-channel EEG signal | During 15 days of motor rehabilitation training |
| Slow-wave activity | Single-channel sleep EEG: [µV^2/Hz or % or dB of baseline if normalized] in scored non-rapid eye movement (NREM) sleep from frontal, single-channel EEG signal | During 15 days of motor rehabilitation training |
| Sigma power | Single-channel sleep EEG: [µV^2/Hz or % or dB of baseline if normalized] in scored NREM sleep from frontal, single-channel EEG signal | During 15 days of motor rehabilitation training |
| Quantity | Single-channel sleep EEG: density [number/min], and characteristics (amplitude, peak frequency, bandwidth) of sleep oscillations (spindles, K-complexes, slow-wave-spindle-coupling) in scored NREM sleep from frontal, single-channel EEG signal. | During 15 days of motor rehabilitation training |
| Quality of Life (EQ-5D-5L) | Patient-Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. Quality of life scale developed by EuroQol Group called EQ-5D-5L, scoring from level 1 indicating no problem to level 5 indicating extreme problems. | Pre motor rehabilitation training and 1 month after training |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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