Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06466772

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

Led by University of Zurich · Updated on 2024-06-20

40

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

U

University of Zurich

Lead Sponsor

E

ETH Zurich (Switzerland)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ischemic stroke or intracerebral hemorrhage with a gait deficit older than 30 days but not more than 6 months
  • Functional Ambulation Category score of 3 or higher
  • 18 years of age or older
  • Provided informed consent by signing
Not Eligible

You will not qualify if you...

  • Cognitive impairment with Montreal Cognitive Assessment (MoCa) score below 20
  • Comprehensive aphasia preventing understanding of study information
  • Previous stroke causing lasting cognitive, visual, or gait problems
  • Expected acute hospitalization during training period
  • History of physical or neurological condition interfering with study procedures
  • Social or personal circumstances preventing attendance at therapy and follow-ups
  • Inability to voluntarily adapt gait
  • Allergy to nickel
  • Use of benzodiazepines or Z-drugs that significantly affect sleep EEG

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, 8091

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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