Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

NCT06608875 | Recruiting

• 1 other identifier: 2023-01400
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 6 min walking test

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

  Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation

• MiniBEST test

  the change in postural stability assessed with the MiniBEST test

  Pre, immediately post motor rehabilitation and 1 month post motor rehabilitation

Secondary Outcomes (6)

• Phase Coordination Index

  Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training

• Continuous Relative Phase

  Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training

• Variability

  Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training

• Symmetry

  Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training

• Margin of Stability

  Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training

Other Outcomes (7)

• Standard sleep architecture measures

  During 15 days of motor rehabilitation training

• Event related spectral perturbation (ERSP)

  During 15 days of motor rehabilitation training

• Frequency spectrum

  During 15 days of motor rehabilitation training

Study Arms (2)

Adaptation Arm

SHAM COMPARATOR

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

Behavioral: Hyper-personalized feedback (HPF intervention); Behavioral: Control targeted auditory stimulation during sleep (TASS sham intervention)

Consolidation arm

EXPERIMENTAL

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

Behavioral: Hyper-personalized feedback (HPF intervention); Behavioral: Targeted auditory stimulation during sleep (TASS verum intervention)

Interventions

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.

Adaptation Arm; Consolidation arm

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

Consolidation arm

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)

Adaptation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (participant, care provider, investigator, outcomes assessor).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Consolidation Arm: hyper-personalized feedback based-motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS intervention)

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: September 23, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)