Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

NCT06466772 | Recruiting

• 1 other identifier: 2022-01194
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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

Stroke

Outcome Measures

Primary Outcomes (1)

• 6 min walking test (6MWT)

  Change in functional walking ability assessed with the 6 min walking test (6MWT)

  Pre, immediately post motor rehabilitation training and one-month post-training

Secondary Outcomes (1)

• Gait kinematics

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

Other Outcomes (4)

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

  During 15 days of motor rehabilitation training

• Sleep hdEEG + EMG + EOG

  Pre motor rehabilitation training

• Wake hdEEG

  Pre and immediately post 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: 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: April 11, 2024
• First Posted: June 20, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)