Clinical trial NCT06466772: Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
Official title: Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich (Switzerland)
name: Cereneo AG
name: University Children's Hospital, Zurich
name: Vontobel-Stiftung
First posted: 2024-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consolidation arm: hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS intervention)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6 min walking test (6MWT)
timeFrame: Pre, immediately post motor rehabilitation training and one-month post-training
Secondary outcomes:
measure: Gait kinematics
timeFrame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Other outcomes:
measure: Single-channel sleep EEG (Electroencephalography)+ EMG (Electroencephalography) + EOG (Electrooculography)
timeFrame: During 15 days of motor rehabilitation training
measure: Sleep hdEEG + EMG + EOG
timeFrame: Pre motor rehabilitation training
measure: Wake hdEEG
timeFrame: Pre and immediately post motor rehabilitation training
measure: Quality of Life (EQ-5D-5L)
timeFrame: Pre motor rehabilitation training and 1 month after training
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
References: