Stroke SequelaeRECOMMENCERNCT05511207
Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke
A study testing RECOM - hBCI training and CTRL - upper limb training with FES in people with Stroke Sequelae and Motor Disorders, run by Donatella Mattia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Sequelae, Motor Disorders
- What is being tested?
- RECOM - hBCI training and CTRL - upper limb training with FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral stroke event at least 3 months before recruitment
- reduced strength in the upper limb
Who cannot join
- concomitant diseases affecting upper limb function
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS
Rome, Italy, 00179
About this study
Official title: RECOMmENceR: RE-establishing COrtico Muscular COMunication to ENhance Recovery. Clinical Validation of BCI-controlled Functional Electrical Stimulation for Upper Limb Rehabilitation After Stroke
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).
Read the detailed description
Brain-Computer Interface (BCI) systems for upper limb rehabilitation have proven some efficacy in the context of several randomized controlled trials (RCT). Such systems rely on the possibility reinforce motor-related brain activity (derived eg from electroencephalography, EEG) harnessing neuroplasticity phenomena ultimately leading to favorable motor outcome. Up to now, no hybrid BCI (hBCI) has been tested successfully for this purpose in a clinical trial. Hybrid BCIs include signals from the periphery (most commonly muscles, via surface electromyography, EMG) and are usually employed to improve BCI performances. In a rehabilitative context, the investigators aim to employ EMG signals to characterize common post-stroke abnormalities (spasticity, co-contractions, motor overflow) and possibly include those in a novel hBCI paradigm to promote both volitional control (EEG) over upper limb movement and "close to normal" muscular activation (EMG). To do so, the investigators propose cortico-muscular coherence (CMC) as a hybrid feature for BCI control. CMC is a measure of EEG-EMG synchronization during movement and has been described extensively in post-stroke patients in relation to their residual motor ability. With respect to previous literature, the proposed approach foresees the estimation of CMC as a multimodal integrated EEG-EMG network, comprising multiple EEG electrodes over the scalp bilaterally and several upper limb muscles bilaterally, so as to capture the above mentioned motor abnormalities (eg abnormal recruitment of non-target muscles). The investigators have already tested such feature on healthy subjects and stroke patients offline and verified its capability to detect upper limb movements online (studies published and/or submitted, see references). An already available BCI prototype was adapted with the parameters derived from such offline studies (see references). The RECOM intervention will be validated within a RCT (single blinded, for evaluators) on stroke patients undergoing rehabilitation (add-on). Before and after the intervention, all patients will undergo an extensive clinical evaluation (see outcome measures) and neurophysiological assessment. The latter will consist in a high density EEG-EMG recording during simple/complex upper limb movements. The recording will include a cinematic analysis (inertial measurement units - IMUs). The investigators hypothesize a better functional motor outcome in the affected upper limb for the RECOM group, which will be described by means of common clinical/functional scales combined with EEG/EMG and cinematic evaluation. Furthermore, aspects related to acceptability and usability of the novel system will be evaluated. In detail mood, motivation and satisfaction will be evaluated before (mood motivation) and after (satisfaction) each training session by means of Visual Analogue Scales; workload will be evaluated at the end of second and last training session by means of the Nasa-Task Load Index.
- Conditions
- Stroke Sequelae, Motor Disorders
- Being tested
- RECOM - hBCI training, CTRL - upper limb training with FES
- Keywords
- stroke, eeg, emg, cortico-muscular coherence, brain computer interface
- Medical subject headings
- Motor Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECOM - hBCI trainingDevice
The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks.
CTRL - upper limb training with FESOther
An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| RECOM - hBCI training | Experimental | Patients in the RECOM group will receive treatment in add-on to standard rehabilitation as follows. The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks. Receives: Device: RECOM - hBCI training |
| CTRL - upper limb training with FES | Active comparator | Patients in the CTRL group will receive treatment in add-on to standard rehabilitation as follows. An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks. Receives: Other: CTRL - upper limb training with FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fugl-Meyer Assessment (FMA) - upper limb section
Commonly employed functional scale for post-stroke motor function. The scale ranges from 0 (maximum possible impairment) to 66 (no impairment).
Measured: Pre-Randomization, Post Training (within 48 hours)
Changes in Action Research Arm Test (ARAT)
Commonly employed functional scale for post-stroke upper limb function. Consists of 19 items with a four scale point. Total scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Measured: Pre-Randomization, Post Training (within 48 hours)
Secondary outcomes (5)
Changes in Modified Ashworth Scale for Spasticity (MAS)
Measure of arm spasticity (at shoulder + elbow + hand) as measured by means of MAS (score from 0 to 5 points, where 0 is equal to absence of spasticity, 5 is equal to high degree of spasticity)
Measured: Pre-Randomization, Post Training (within 48 hours)
Changes Box and Block Test (BBT)
The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
Measured: Pre-Randomization, Post Training (within 48 hours)
Changes Numeric Rating Scale for pain in the upper limb (NRS)
Measure of arm perceived pain by means of Numeric Rating Scale (score from 0 to 10 points where 0 is equal to NO PAIN and 10 is equal to UNSPEAKABLE PAIN)
Measured: Pre-Randomization, Post Training (within 48 hours)
Changes in Manual Muscle Test (MMT) strength in upper limb segments
Evaluation of residual strength in upper limb muscles - shoulder abduction, elbow flexion and extension, wrist flexion and extension (each segment ranging from 0 - no muscular activation to 5 - full movement against resistance).
Measured: Pre-Randomization, Post Training (within 48 hours)
Changes in NIH Stroke Scale
Measure of severity of stroke symptoms as for the National Institute of Health Stroke Scale-NIHSS (composed by 11 items with a total score ranging from 0 to a maximum depending on each item, where 0 is normal and maximum is pathological response)
Measured: Pre-Randomization, Post Training (within 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Mar 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- 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
- Eligible patients admitted to Fondazione Santa Lucia will be randomized in equal proportions between target intervention (RECOM) and control (CTRL)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donatella Mattia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Sponsor-investigator, Donatella Mattia, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Floriana Pichiorri, MD, PhD, Principal investigator, Fondazione Santa Lucia, IRCCSJlenia Toppi, Prof, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511207
- Sponsor's protocol ID
- GR-2018-12365874
- Other IDs
- GR18.74
- Acronym
- RECOMMENCER
- Status last verified
- Oct 2024
- First submitted
- 12 Aug 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Neurophysiological Data (EEG, EMG, cinematic) will be shared upon reasonable request (anonymized)
Publications
Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.
PubMed 25712802Peng Y, Wang J, Liu Z, Zhong L, Wen X, Wang P, Gong X, Liu H. The Application of Brain-Computer Interface in Upper Limb Dysfunction After Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Hum Neurosci. 2022 Mar 29;16:798883. doi: 10.3389/fnhum.2022.798883. eCollection 2022.
PubMed 35422693Chen YT, Li S, Magat E, Zhou P, Li S. Motor Overflow and Spasticity in Chronic Stroke Share a Common Pathophysiological Process: Analysis of Within-Limb and Between-Limb EMG-EMG Coherence. Front Neurol. 2018 Oct 9;9:795. doi: 10.3389/fneur.2018.00795. eCollection 2018.
PubMed 30356703Silva CC, Silva A, Sousa A, Pinheiro AR, Bourlinova C, Silva A, Salazar A, Borges C, Crasto C, Correia MV, Vilas-Boas JP, Santos R. Co-activation of upper limb muscles during reaching in post-stroke subjects: an analysis of the contralesional and ipsilesional limbs. J Electromyogr Kinesiol. 2014 Oct;24(5):731-8. doi: 10.1016/j.jelekin.2014.04.011. Epub 2014 May 9.
PubMed 24882699von Carlowitz-Ghori K, Bayraktaroglu Z, Hohlefeld FU, Losch F, Curio G, Nikulin VV. Corticomuscular coherence in acute and chronic stroke. Clin Neurophysiol. 2014 Jun;125(6):1182-91. doi: 10.1016/j.clinph.2013.11.006. Epub 2013 Nov 16.
PubMed 24315544Pichiorri F, Mattia D. Brain-computer interfaces in neurologic rehabilitation practice. Handb Clin Neurol. 2020;168:101-116. doi: 10.1016/B978-0-444-63934-9.00009-3.
PubMed 32164846Colamarino E, de Seta V, Masciullo M, Cincotti F, Mattia D, Pichiorri F, Toppi J. Corticomuscular and Intermuscular Coupling in Simple Hand Movements to Enable a Hybrid Brain-Computer Interface. Int J Neural Syst. 2021 Nov;31(11):2150052. doi: 10.1142/S0129065721500520. Epub 2021 Sep 30.
PubMed 34590990
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOMmENceR: RE-establishing COrtico Muscular COMunication to ENhance Recovery. Clinical Validation of BCI-controlled Functional Electrical Stimulation for Upper Limb Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT05511207
- Acronym / sponsor ID
- RECOMMENCER / GR-2018-12365874
- Conditions
- Stroke Sequelae, Motor Disorders
- Keywords
- stroke, eeg, emg, cortico-muscular coherence, brain computer interface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Donatella MattiaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Aug 2022 (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.
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).
Detailed description
Brain-Computer Interface (BCI) systems for upper limb rehabilitation have proven some efficacy in the context of several randomized controlled trials (RCT). Such systems rely on the possibility reinforce motor-related brain activity (derived eg from electroencephalography, EEG) harnessing neuroplasticity phenomena ultimately leading to favorable motor outcome. Up to now, no hybrid BCI (hBCI) has been tested successfully for this purpose in a clinical trial. Hybrid BCIs include signals from the periphery (most commonly muscles, via surface electromyography, EMG) and are usually employed to improve BCI performances. In a rehabilitative context, the investigators aim to employ EMG signals to characterize common post-stroke abnormalities (spasticity, co-contractions, motor overflow) and possibly include those in a novel hBCI paradigm to promote both volitional control (EEG) over upper limb movement and "close to normal" muscular activation (EMG). To do so, the investigators propose cortico-muscular coherence (CMC) as a hybrid feature for BCI control. CMC is a measure of EEG-EMG synchronization during movement and has been described extensively in post-stroke patients in relation to their residual motor ability. With respect to previous literature, the proposed approach foresees the estimation of CMC as a multimodal integrated EEG-EMG network, comprising multiple EEG electrodes over the scalp bilaterally and several upper limb muscles bilaterally, so as to capture the above mentioned motor abnormalities (eg abnormal recruitment of non-target muscles). The investigators have already tested such feature on healthy subjects and stroke patients offline and verified its capability to detect upper limb movements online (studies published and/or submitted, see references). An already available BCI prototype was adapted with the parameters derived from such offline studies (see references). The RECOM intervention will be validated within a RCT (single blinded, for evaluators) on stroke patients undergoing rehabilitation (add-on). Before and after the intervention, all patients will undergo an extensive clinical evaluation (see outcome measures) and neurophysiological assessment. The latter will consist in a high density EEG-EMG recording during simple/complex upper limb movements. The recording will include a cinematic analysis (inertial measurement units - IMUs). The investigators hypothesize a better functional motor outcome in the affected upper limb for the RECOM group, which will be described by means of common clinical/functional scales combined with EEG/EMG and cinematic evaluation. Furthermore, aspects related to acceptability and usability of the novel system will be evaluated. In detail mood, motivation and satisfaction will be evaluated before (mood motivation) and after (satisfaction) each training session by means of Visual Analogue Scales; workload will be evaluated at the end of second and last training session by means of the Nasa-Task Load Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients admitted to Fondazione Santa Lucia will be randomized in equal proportions between target intervention (RECOM) and control (CTRL)
| Arm | Type | Receives |
|---|---|---|
| RECOM - hBCI training | Experimental | Device: RECOM - hBCI trainingPatients in the RECOM group will receive treatment in add-on to standard rehabilitation as follows. The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks. |
| CTRL - upper limb training with FES | Active comparator | Other: CTRL - upper limb training with FESPatients in the CTRL group will receive treatment in add-on to standard rehabilitation as follows. An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral stroke event at least 3 months before recruitment
- reduced strength in the upper limb
Key exclusion criteria (4 listed)
- concomitant diseases affecting upper limb function
- 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
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 |
|---|---|---|
| RECOM - hBCI trainingThe RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks. | Device | RECOM - hBCI training |
| CTRL - upper limb training with FESAn expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks. | Other | CTRL - upper limb training with FES |
Primary outcome
Changes in Fugl-Meyer Assessment (FMA) - upper limb section
Time frame: Pre-Randomization, Post Training (within 48 hours)
Commonly employed functional scale for post-stroke motor function. The scale ranges from 0 (maximum possible impairment) to 66 (no impairment).
Changes in Action Research Arm Test (ARAT)
Time frame: Pre-Randomization, Post Training (within 48 hours)
Commonly employed functional scale for post-stroke upper limb function. Consists of 19 items with a four scale point. Total scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
5 secondary outcomes
Changes in Modified Ashworth Scale for Spasticity (MAS)
Time frame: Pre-Randomization, Post Training (within 48 hours)
Changes Box and Block Test (BBT)
Time frame: Pre-Randomization, Post Training (within 48 hours)
Changes Numeric Rating Scale for pain in the upper limb (NRS)
Time frame: Pre-Randomization, Post Training (within 48 hours)
Changes in Manual Muscle Test (MMT) strength in upper limb segments
Time frame: Pre-Randomization, Post Training (within 48 hours)
Changes in NIH Stroke Scale
Time frame: Pre-Randomization, Post Training (within 48 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 25712802Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.
- Background: PubMed 35422693Peng Y, Wang J, Liu Z, Zhong L, Wen X, Wang P, Gong X, Liu H. The Application of Brain-Computer Interface in Upper Limb Dysfunction After Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Hum Neurosci. 2022 Mar 29;16:798883. doi: 10.3389/fnhum.2022.798883. eCollection 2022.
- Background: PubMed 30356703Chen YT, Li S, Magat E, Zhou P, Li S. Motor Overflow and Spasticity in Chronic Stroke Share a Common Pathophysiological Process: Analysis of Within-Limb and Between-Limb EMG-EMG Coherence. Front Neurol. 2018 Oct 9;9:795. doi: 10.3389/fneur.2018.00795. eCollection 2018.
- Background: PubMed 24882699Silva CC, Silva A, Sousa A, Pinheiro AR, Bourlinova C, Silva A, Salazar A, Borges C, Crasto C, Correia MV, Vilas-Boas JP, Santos R. Co-activation of upper limb muscles during reaching in post-stroke subjects: an analysis of the contralesional and ipsilesional limbs. J Electromyogr Kinesiol. 2014 Oct;24(5):731-8. doi: 10.1016/j.jelekin.2014.04.011. Epub 2014 May 9.
- Background: PubMed 24315544von Carlowitz-Ghori K, Bayraktaroglu Z, Hohlefeld FU, Losch F, Curio G, Nikulin VV. Corticomuscular coherence in acute and chronic stroke. Clin Neurophysiol. 2014 Jun;125(6):1182-91. doi: 10.1016/j.clinph.2013.11.006. Epub 2013 Nov 16.
- Background: PubMed 32164846Pichiorri F, Mattia D. Brain-computer interfaces in neurologic rehabilitation practice. Handb Clin Neurol. 2020;168:101-116. doi: 10.1016/B978-0-444-63934-9.00009-3.
- Results publication: PubMed 34590990Colamarino E, de Seta V, Masciullo M, Cincotti F, Mattia D, Pichiorri F, Toppi J. Corticomuscular and Intermuscular Coupling in Simple Hand Movements to Enable a Hybrid Brain-Computer Interface. Int J Neural Syst. 2021 Nov;31(11):2150052. doi: 10.1142/S0129065721500520. Epub 2021 Sep 30.
- Description of available Hybrid BCI prototypeLink provided by the sponsor.
- Adaptation of Hybrid BCI prototypeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Neurophysiological Data (EEG, EMG, cinematic) will be shared upon reasonable request (anonymized)
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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. This study is not recruiting at the moment.
Floriana Pichiorri, MD, PhD principal investigator
Fondazione Santa Lucia, IRCCS
Jlenia Toppi, Prof principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECOM - hBCI training and CTRL - upper limb training with FES in people with Stroke Sequelae and Motor Disorders, run by Donatella Mattia at 1 site in Italy.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fugl-Meyer Assessment (FMA) - upper limb section (time frame: Pre-Randomization, Post Training (within 48 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511207, which also lists 7 linked publications.
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 17 Mar 2025.