StrokeStimuLOOP-SNCT06466772
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
A study testing Hyper-personalized feedback (HPF intervention) and Targeted auditory stimulation during sleep (TASS verum intervention) in people with Stroke, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Hyper-personalized feedback (HPF intervention) and Targeted auditory stimulation during sleep (TASS verum intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Not capable of voluntary gait adaptation
- Allergy to nickel
- Patients taking benzodiazepines or Z-drugs with a significant effect on sleep EEG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Yannik Rottenberger, +41 44 255 55 11, yannik.rottenberger@usz.ch
About this study
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.
Read more
- 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.
- 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
- Stroke
- Being tested
- Hyper-personalized feedback (HPF intervention), Targeted auditory stimulation during sleep (TASS verum intervention), Control targeted auditory stimulation during sleep (TASS sham intervention)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyper-personalized feedback (HPF intervention)Behavioural
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)Behavioural
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)Behavioural
Identical auditory presentation during the motor rehabilitation training, but not during the night (sham promotion memory reactivation)
| Study group | Role | What they receive |
|---|---|---|
| Adaptation arm | Sham comparator | Hyper-personalized feedback-based motor rehabilitation with sham targeted auditory stimulation during sleep (HPF intervention, TASS sham intervention) Receives: 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) Receives: Behavioral: Hyper-personalized feedback (HPF intervention); Behavioral: Targeted auditory stimulation during sleep (TASS verum intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walking test (6MWT)
Change in functional walking ability assessed with the 6 min walking test (6MWT)
Measured: Pre, immediately post motor rehabilitation training and one-month post-training
Secondary outcomes (1)
Gait kinematics
Motor learning assessed via changes in gait kinematics: variability, symmetry, coordination, stability.
Measured: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start13 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consolidation arm: hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS intervention)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland), Cereneo AG, University Children's Hospital, Zurich, Vontobel-Stiftung
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466772
- Sponsor's protocol ID
- 2022-01194
- Acronym
- StimuLOOP-S
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
- ClinicalTrials.gov ID
- NCT06466772
- Acronym / sponsor ID
- StimuLOOP-S / 2022-01194
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland), Cereneo AG, University Children's Hospital, Zurich, Vontobel-Stiftung
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Consolidation arm: hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS intervention)
| Arm | Type | Receives |
|---|---|---|
| Adaptation arm | Sham comparator | Behavioral: Hyper-personalized feedback (HPF intervention), Behavioral: Control targeted auditory stimulation during sleep (TASS sham intervention)Hyper-personalized feedback-based motor rehabilitation with sham targeted auditory stimulation during sleep (HPF intervention, TASS sham intervention) |
| Consolidation arm | Experimental | Behavioral: Hyper-personalized feedback (HPF intervention), Behavioral: Targeted auditory stimulation during sleep (TASS verum intervention)Hyper-personalized feedback-based motor rehabilitation with targeted auditory stimulation during sleep (HPF intervention, TASS verum intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Adaptation arm, Consolidation arm |
| 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 | Behavioural | Consolidation arm |
| 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) | Behavioural | Adaptation arm |
Primary outcome
6 min walking test (6MWT)
Time frame: Pre, immediately post motor rehabilitation training and one-month post-training
Change in functional walking ability assessed with the 6 min walking test (6MWT)
1 secondary outcome
Gait kinematics
Time frame: Pre, immediately post motor rehabilitation training and during 15 days of motor rehabilitation training and one-month post-training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyper-personalized feedback (HPF intervention) and Targeted auditory stimulation during sleep (TASS verum intervention) in people with Stroke, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 min walking test (6MWT) (time frame: Pre, immediately post motor rehabilitation training and one-month post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.