Advancing Upper Limb Stroke Rehab & Assistive Technology
Summary description of the study
This clinical project aims to improve motor control of the affected arm in individuals who have suffered a stroke by combining non-invasive multifocal brain stimulation with the innovative use of a touchscreen tablet for motor learning. Currently, many post-stroke patients face difficulties with motor control, which limits their independence and quality of life. Conventional rehabilitation approaches have shown their limitations, highlighting the need for innovation. By using multifocal brain stimulation and an interactive interface via a touchscreen tablet, this project aims to optimize motor learning and enhance motor recovery in these patients. By evaluating the effectiveness of this approach, we aim to provide new perspectives for post-stroke rehabilitation and improve the quality of life for patients.
(BASEC)
Intervention under investigation
Intermittent Theta Burst Stimulation (iTBS): The Magstim®Rapid2 system (© The Magstim Company Limited, Spring Gardens, UK - Class IIa)
(BASEC)
Disease under investigation
Stroke
(BASEC)
Stroke Patients 1) Age ≥ 18 years 2) First hemorrhagic or ischemic stroke ≤ 6 months 3) Unilateral hemiparesis of the upper limb with a FMA-UE score (29 ≤ Score < 58) Healthy Participants 1) Age ≥ 18 years 2) Ability to concentrate and follow the study protocol 3) Provided informed consent (BASEC)
Exclusion criteria
Stroke Patients 1) Injection of botulinum toxin in the upper limb less than 3 months before the start of the protocol 2) Patients who have experienced one or more seizures 3) Metallic object near the stimulated area Healthy Participants 1) Severe comorbidity of the non-dominant arm (traumatic, rheumatological, osteoarticular neurodegenerative diseases). 2) Inability to follow study procedures, for example due to language problems, psychological disorders, dementia, etc. of the participant 3) Current or past use of psychoactive substances, including drug use or excessive alcohol consumption (BASEC)
Trial sites
Geneva
(BASEC)
Sponsor
Dr Nicolas Nicastro Médecin adjoint agrégé responsable d’unité Spéc. FMH en Neurologie Département des Neurosciences Cliniques, Service de Neurorééducation, Hôpitaux Universitaire de Genève
(BASEC)
Contact
Contact Person Switzerland
Pierre Nicolo
0792633543
pierre.nicolo@clutterhesge.chHaute école de santé / University School of Health ▪ HES-SO Genève
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
16.07.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Advancing stroke rehabilitation through multifocal network-based theta-burst stimulation and assistive technology: Enhancing upper limb motor learning: A single-center, randomized, sham-controlled study with parallel groups. (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available