Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
NCT Number: NCT06466772
Acronym: StimuLOOP-S
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: BEHAVIORAL: Hyper-personalized feedback (HPF intervention)|BEHAVIORAL: Targeted auditory stimulation during sleep (TASS verum intervention)|BEHAVIORAL: Control targeted auditory stimulation during sleep (TASS sham intervention)
Sponsor: University of Zurich
Collaborators: ETH Zurich (Switzerland)|Cereneo AG|University Children's Hospital, Zurich|Vontobel-Stiftung
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-13
Completion Date: 2026-12
Locations: University Hospital Zurich, Zürich, Zurich, 8091, Switzerland

Summary:
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.

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 the first step, the investigator will choose what movement aspect is therapeutically targeted, and in the second step, the investigator will define the feedback 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.

Primary Outcome Measures: 6 min walking test (6MWT), Change in functional walking ability assessed with the 6 min walking test (6MWT), Pre, immediately post motor rehabilitation training and one-month post-training
Secondary Outcome Measures: Gait kinematics, Motor learning assessed via changes in gait kinematics: variability, symmetry, coordination, stability., Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Other Outcome Measures: 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, 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, 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, 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., Pre motor rehabilitation training and 1 month after training