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NCT Number: NCT06466772

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location status: Recruiting

Location contact

Yannik Rottenberger

CONTACT

[email protected]

+41 44 255 55 11

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyper-personalized feedback (HPF intervention)

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)

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

Control targeted auditory stimulation during sleep (TASS sham intervention)

Behavioral

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

Primary outcomes

  1. 6 min walking test (6MWT)

    Time frame: 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 outcomes

  1. Gait kinematics

    Time frame: 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 outcomes

  1. Single-channel sleep EEG (Electroencephalography)+ EMG (Electroencephalography) + EOG (Electrooculography)

    Time frame: 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

  2. Sleep hdEEG + EMG + EOG

    Time frame: 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

  3. Wake hdEEG

    Time frame: 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

  4. Quality of Life (EQ-5D-5L)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Cereneo AG
  • ETH Zurich (Switzerland)
  • University Children's Hospital, Zurich
  • Vontobel-Stiftung

Registry information

Acronym: StimuLOOP-S

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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