Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

Stroke Clinical Trial

— StimuLOOP-S  

Official title:

Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466772
• Other study ID #: 2022-01194
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Hyper-personalized feedback (HPF intervention)
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)
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)
Identical auditory presentation during the motor rehabilitation training, but not during the night (sham promotion memory reactivation)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	Cereneo AG, ETH Zurich (Switzerland), University Children's Hospital, Zurich, Vontobel-Stiftung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single-channel sleep EEG (Electroencephalography)+ EMG (Electroencephalography) + EOG (Electrooculography)	Single-channel sleep EEG (Electroencephalography): sleep architecture, ERSP, ERP, frequency spectrum, slow-wave activity changes, changes in the spindle band, sleep oscillation detection (K-complexes, spindles, slow-wave-spindle-coupling); EMG ( Electromyography): signal from the chin recorded during sleep will be filtered between 10 and 100 Hz and re-referenced bilaterally according to AASM criteria and used for offline sleep staging; EOG (Electrooculography): filtered between 0.3 and 35 Hz and used for offline sleep staging.; EOG and EMG are only used for sleep scoring	During 15 days of motor rehabilitation training
Other	Sleep hdEEG + EMG + EOG	Sleep high density EEG: sleep architecture, slow-wave activity topography, spindle band topography, ERSP, ERP, frequency spectrum, sleep oscillation detection (K-complexes, spindles, slow-wave-spindle-coupling).; EOG (Electrooculography)and EMG ( Electromyography) are only used for sleep scoring	Pre motor rehabilitation training
Other	Wake hdEEG	Wake high density EEG: theta topography, alpha topography, frequency spectrum at resting state, ERP in oddball task, ERSP in oddball task, characterization of wake slow waves if detectable	Pre and immediately post motor rehabilitation training
Other	Quality of Life (EQ-5D-5L)	Patient-Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease.	Pre motor rehabilitation training and 1 month after training
Primary	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	Gait kinematics	Motor learning assessed via changes in gait kinematics: variability, symmetry, coordination, stability.	Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training