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NCT Number: NCT06608875

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

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.

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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

Angelina Maric

CONTACT

[email protected]

+41 44 255 86 15

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Idiopathic Parkinson's disease with gait and postural stability deficits
  • ≥18 years of age
  • United Parkinson Disease Rating Scale (UPDRS) III gait scores 1-3
  • UPDRS III postural instability scores 1-3
  • Prescribed rehabilitation therapy at cereneo
  • Informed consent as documented by signature
  • Adjustments in dopaminergic medication and deep brain stimulation (DBS) to improve motor symptoms implemented to the current best possible extent

Exclusion criteria

  • Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20
  • Comprehensive aphasia precluding the understanding of study-related information
  • Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability 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
  • Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
  • Recent DBS implant (≤ 6 months)
  • Inability to perform outcome assessments without walking aid
  • Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)

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

    Time frame: Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation

    Change in functional walking ability assessed with the 6 min walking test

  2. MiniBEST test

    Time frame: Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation

    the change in postural stability assessed with the MiniBEST test

Secondary outcomes

  1. Phase Coordination Index

    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 coordination. Coordination assessed using the Phase Coordination Index.

  2. Continuous Relative Phase

    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 coordination. Coordination assessed using Continous Relative Phase.

  3. Variability

    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 variability. Variability assessed using the coefficient of variation (%CV) of common spatio-temporal gait parameters, including stride time, stride length, step length, swing time, stance time, step width, and double limb support time.

  4. Symmetry

    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 symmetry. Symmetry (%) in step length and step time.

  5. Margin of Stability

    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 stability. Stability assessed using Margin of Stability.

  6. Resilience

    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 stability: Stability assessed using resilience metrics.

Other outcomes

  1. Standard sleep architecture measures

    Time frame: During 15 days of motor rehabilitation training

    Single-channel sleep Electroencephalography (EEG): (e.g. % N3, % N2, wake after sleep onset, Sleep efficiency) from scored EEG, electromyography (EMG), and electrooculography (EOG) signal (note: bandpass filtered EMG and EOG signal will only be used for offline sleep scoring according to American Academy of Sleep Medicine standards)

  2. Event related spectral perturbation (ERSP)

    Time frame: During 15 days of motor rehabilitation training

    ERSP: [µV^2/Hz or % or dB of baseline if normalized over time] and event-related potential (ERP) [µV over time] locked to stimuli from frontal, single-channel EEG signal

  3. Frequency spectrum

    Time frame: During 15 days of motor rehabilitation training

    Single-channel sleep EEG: [µV^2/Hz] from frontal, single-channel EEG signal

  4. Slow-wave activity

    Time frame: During 15 days of motor rehabilitation training

    Single-channel sleep EEG: [µV^2/Hz or % or dB of baseline if normalized] in scored non-rapid eye movement (NREM) sleep from frontal, single-channel EEG signal

  5. Sigma power

    Time frame: During 15 days of motor rehabilitation training

    Single-channel sleep EEG: [µV^2/Hz or % or dB of baseline if normalized] in scored NREM sleep from frontal, single-channel EEG signal

  6. Quantity

    Time frame: During 15 days of motor rehabilitation training

    Single-channel sleep EEG: density [number/min], and characteristics (amplitude, peak frequency, bandwidth) of sleep oscillations (spindles, K-complexes, slow-wave-spindle-coupling) in scored NREM sleep from frontal, single-channel EEG signal.

  7. 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.

    Quality of life scale developed by EuroQol Group called EQ-5D-5L, scoring from level 1 indicating no problem to level 5 indicating extreme problems.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Cereneo AG
  • ETH Zurich (Switzerland)
  • Lake Lucerne Institute AG
  • University Children's Hospital, Zurich

Registry information

Official study title

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study

Acronym: StimuLOOP-PD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Oct 1, 2024

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

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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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