Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06608875

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

Led by University of Zurich · Updated on 2024-10-01

40

Participants Needed

1

Research Sites

132 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

Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of 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.PD intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigator will conduct a proof-of-concept study to investigate a combination of two methods that are each tailored to the individual patient. Two innovative technologies are applied in concert to enhance 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 a first step, the investigator will choose what movement aspect is therapeutically targeted, and in a second step, the investigator will define how the feedback is 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...

  • Idiopathic Parkinson's disease with gait and postural stability deficits
  • 18 years of age or older
  • United Parkinson Disease Rating Scale (UPDRS) III gait scores between 1 and 3
  • UPDRS III postural instability scores between 1 and 3
  • Prescribed rehabilitation therapy at cereneo
  • Provided informed consent by signature
  • Dopaminergic medication and deep brain stimulation (DBS) optimized to the best possible extent for motor symptoms
Not Eligible

You will not qualify if you...

  • Cognitive impairment with Montreal Cognitive Assessment (MoCa) score less than 20
  • Severe aphasia preventing understanding of study information
  • Other neurological or medical conditions causing significant gait or balance problems
  • Expected acute hospitalization during training period
  • History of physical or neurological conditions interfering with study procedures
  • Social or personal issues preventing attendance to therapy and follow-up
  • Inability to voluntarily adapt gait
  • Use of benzodiazepines or Z-drugs significantly affecting sleep EEG
  • Deep brain stimulation (DBS) implant within the last 6 months
  • Unable to perform outcome assessments without walking aid
  • Skin problems or allergies in face or ear area that may worsen with electrode application (e.g., nickel allergy)

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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