An interventional study of Hyper-personalized feedback (HPF intervention) and Targeted auditory stimulation during sleep (TASS verum intervention) in Stroke, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
Stroke is the most common neurological disease in 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.S intends to foster structured and reproducible methods for precision neurorehabilitation of gait in stroke. The investigator will carry out a proof-of-concept study to investigate the integration of two personalized methods for each patient. Two innovative technologies are applied in concert to enhance the 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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Hyper-personalized feedback-based motor rehabilitation with sham targeted auditory stimulation during sleep (HPF intervention, TASS sham intervention)
Behavioral: Hyper-personalized feedback (HPF intervention) · Behavioral: Control targeted auditory stimulation during sleep (TASS sham intervention)
Hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS verum intervention)
Behavioral: Hyper-personalized feedback (HPF intervention) · Behavioral: Targeted auditory stimulation during sleep (TASS verum intervention)
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)
6 min walking test (6MWT)
Change in functional walking ability assessed with the 6 min walking test (6MWT)
Time frame: Pre, immediately post motor rehabilitation training and one-month post-training
Gait kinematics
Motor learning assessed via changes in gait kinematics: variability, symmetry, coordination, stability.
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Single-channel sleep EEG (Electroencephalography)+ EMG (Electroencephalography) + EOG (Electrooculography)
Single-channel sleep EEG (Electroencephalography): sleep architecture, ERSP, ERP, frequency spectrum, slow-wave activity changes, changes in the spindle band, sleep oscillation detection (K-complexes, spindles, slow-wave-spindle-coupling) EMG ( Electromyography): signal from the chin recorded during sleep will be filtered between 10 and 100 Hz and re-referenced bilaterally according to AASM criteria and used for offline sleep staging EOG (Electrooculography): filtered between 0.3 and 35 Hz and used for offline sleep staging. EOG and EMG are only used for sleep scoring
Time frame: During 15 days of motor rehabilitation training
Sleep hdEEG + EMG + EOG
Sleep high density EEG: sleep architecture, slow-wave activity topography, spindle band topography, ERSP, ERP, frequency spectrum, sleep oscillation detection (K-complexes, spindles, slow-wave-spindle-coupling). EOG (Electrooculography)and EMG ( Electromyography) are only used for sleep scoring
Time frame: Pre motor rehabilitation training
Wake hdEEG
Wake high density EEG: theta topography, alpha topography, frequency spectrum at resting state, ERP in oddball task, ERSP in oddball task, characterization of wake slow waves if detectable
Time frame: Pre and immediately post 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.
Time frame: Pre motor rehabilitation training and 1 month after training
Plan to share: No
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University of Zurich