NCT05511207Completed
Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke
RECOMmENceR: RE-establishing COrtico Muscular COMunication to ENhance Recovery. Clinical Validation of BCI-controlled Functional Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
The RECOMMENCER project aims at developing and testing a novel hybrid Brain Computer Interface device based on cortico-muscular connectivity, that will be employed to activate Functional Electrical Stimulation (FES) of upper limb muscles. After the technical implementation of the device and its preliminary testing on healthy subject, the investigators will evaluate the effects of a 1 month training with the device (RECOM) on post-stroke patients undergoing standard rehabilitation (add-on). The proposed intervention will be compared with an active physiotherapy training including FES (CTRL) which will be focused on upper limb with similar intensity as the target intervention (also delivered in add-on).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 12 Aug 2022
- Start date
- Mar 2023
- Primary completion date
- Dec 2024
- Lead sponsor
- Donatella Mattia
- Diseases
- Stroke
- NCT number
- NCT05511207
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From Mar 2023 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concomitant diseases affecting upper limb function
Other
- spasticity in the upper limb (4-5 of MAS)
- severe neuropsychological deficit preventing active participation to the study
- contraindication to FES or EEG/EMG recording
Who the study is looking for
- unilateral stroke event at least 3 months before recruitment
- reduced strength in the upper limb
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.