University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Location status: Recruiting
NCT Number: NCT06608875
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.
1. Hyper-personalized feedback (HPF): 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. This results in a two-step personalization; in a first step, the investigator will choose what movement aspect is therapeutically targeted, and in a second step, the investigator will define how the feedback is presented to the participant. 2. Targeted auditory stimulation during sleep (TASS):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.
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Zurich, Canton of Zurich, 8091, Switzerland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Identical auditory presentation during the motor rehabilitation training, but not during the night (sham promotion memory reactivation)
Time frame: Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation
Change in functional walking ability assessed with the 6 min walking test
Time frame: Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation
the change in postural stability assessed with the MiniBEST test
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Motor learning assessed via changes in coordination. Coordination assessed using the Phase Coordination Index.
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Motor learning assessed via changes in coordination. Coordination assessed using Continous Relative Phase.
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
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.
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Motor learning assessed via changes in symmetry. Symmetry (%) in step length and step time.
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Motor learning assessed via changes in stability. Stability assessed using Margin of Stability.
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Motor learning assessed via changes in stability: Stability assessed using resilience metrics.
Time frame: During 15 days of motor rehabilitation training
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)
Time frame: During 15 days of motor rehabilitation training
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
Time frame: During 15 days of motor rehabilitation training
Single-channel sleep EEG: [µV^2/Hz] from frontal, single-channel EEG signal
Time frame: During 15 days of motor rehabilitation training
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
Time frame: During 15 days of motor rehabilitation training
Single-channel sleep EEG: [µV^2/Hz or % or dB of baseline if normalized] in scored NREM sleep from frontal, single-channel EEG signal
Time frame: During 15 days of motor rehabilitation training
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.
Time frame: Pre motor rehabilitation training and 1 month after training
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.
University of Zurich
Other
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study
Acronym: StimuLOOP-PD
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