Stroke
Conditions
Brief 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.
Interventions
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)
Sponsors
ETH Zurich (Switzerland)
Cereneo AG
University Children's Hospital, Zurich
Vontobel-Stiftung
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Consolidation arm: hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic stroke or intracerebral hemorrhage with a gait deficit older than 30 days but not more than 6 months. * Functional Ambulation Category ≥3 * ≥18 years of age * Informed consent as documented by signature
Exclusion criteria
* Cognitive impairment, Montreal Cognitive Assessment (MoCa) \< 20 * Comprehensive aphasia precluding the understanding of study-related information * Previous stroke that caused sustained clinically relevant cognitive, visual and/or gait deficits * Expected acute hospitalization during the training period * History of a physical or neurological condition that interferes with study procedures * Social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow-up assessments * Not capable of voluntary gait adaptation * Allergy to nickel * Patients taking benzodiazepines or Z-drugs with a significant effect on sleep EEG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 min walking test (6MWT) | Pre, immediately post motor rehabilitation training and one-month post-training | Change in functional walking ability assessed with the 6 min walking test (6MWT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait kinematics | 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 gait kinematics: variability, symmetry, coordination, stability. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Single-channel sleep EEG (Electroencephalography)+ EMG (Electroencephalography) + EOG (Electrooculography) | During 15 days of motor rehabilitation training | 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 |
| Sleep hdEEG + EMG + EOG | Pre motor rehabilitation training | 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 |
| Wake hdEEG | Pre and immediately post motor rehabilitation training | 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 |
| Quality of Life (EQ-5D-5L) | 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. |
Countries
Switzerland
Outcome results
None listed