Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

NCT ID: NCT06466772

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2026-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Adaptation arm

Hyper-personalized feedback-based motor rehabilitation with sham targeted auditory stimulation during sleep (HPF intervention, TASS sham intervention)

Group Type: SHAM_COMPARATOR

Hyper-personalized feedback (HPF intervention)

Intervention Type: BEHAVIORAL

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.

Control targeted auditory stimulation during sleep (TASS sham intervention)

Intervention Type: BEHAVIORAL

Identical auditory presentation during the motor rehabilitation training, but not during the night (sham promotion memory reactivation)

Consolidation arm

Hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS verum intervention)

Group Type: EXPERIMENTAL

Hyper-personalized feedback (HPF intervention)

Intervention Type: BEHAVIORAL

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.

Targeted auditory stimulation during sleep (TASS verum intervention)

Intervention Type: BEHAVIORAL

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

Interventions

Hyper-personalized feedback (HPF 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.

Intervention Type: BEHAVIORAL

Targeted auditory stimulation during sleep (TASS verum intervention)

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

Intervention Type: BEHAVIORAL

Control targeted auditory stimulation during sleep (TASS sham intervention)

Identical auditory presentation during the motor rehabilitation training, but not during the night (sham promotion memory reactivation)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ETH Zurich (Switzerland)

OTHER

Sponsor Role: collaborator

Cereneo AG

INDUSTRY

Sponsor Role: collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role: collaborator

Vontobel-Stiftung

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Yannik Rottenberger

Role: primary

yannik.rottenberger@usz.ch

+41 44 255 55 11

Other Identifiers

2022-01194

Identifier Type: -

Identifier Source: org_study_id