An interventional study of EEG-based BCI system for (hands) Motor Imagery training and Control - MI intervention in Spinal Cord Injuries and Motor Disorders, sponsored by I.R.C.C.S. Fondazione Santa Lucia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by I.R.C.C.S. Fondazione Santa Lucia · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to validate the efficacy of a Brain-Computer Interface (BCI)-based intervention for hand motor recovery in subacute cervical spinal cord injured (SCI) patients during rehabilitation. The study will provide evidence for the clinical/neurophysiological efficacy of the BCI intervention as a means to promote cortical sensorimotor plasticity (remote plasticity) and thus maximize recovery of arm functions in subacute cervical SCI. Participants will undergo an extensive clinical, neurophysiological, neuropsychological and neuroimaging assessment before and after a BCI training based on motor Imagery (MI) of hands. The intervention will be delivered with a system that was originally validated for stroke patients and adapted to the aims of this study. Researchers will compare the BCI intervention with an active MI training without BCI support (active comparator).
Despite its relatively low incidence SCI represents a devastating chronic condition for which there is still no cure or consistent approach for intervention. Cervical SCI tremendously affects the quality of life since the use of the upper extremities is critical for completing basic activities of daily living. Extensive research conducted on SCI animal models and humans has revealed that cortical and subcortical reorganization (ie., remote plasticity) takes place after SCI and it is associated with recovery of sensorimotor function (in humans the relevance of these aspect has been mainly emphasised in incomplete SCI). Current rehabilitation after traumatic SCI mainly consists of intensive training of lost/impaired function that is assumed to augment activity-dependent plasticity of spared circuits and thus, leading to functional improvements. Recently, neuromodulatory interventions targeting the sensorimotor systems at various levels has been applied in humans with SCI in combination with training to enhance functional recovery. Neurological rehabilitation of SCI can also benefit of cognitive training based on MI, that enables active stimulation of brain motor areas promoting brain plasticity associated with positive effects on motor performance. In the effort of encouraging the top-down contribution of supraspinal sensorimotor signaling in SCI rehabilitation, the BCI technology may provide for fundamental tools not only for restoring but even recovering sensorimotor function. The long history of BCI research in SCIs has been substantially devoted to develop systems to control external devices to restore function. However, recent findings indicate that non invasive BCI training in combination with intensive rehabilitation can be beneficial to chronic SCI patients for gait, as well as arm function recovery. The current study relies on the hypothesis that monitoring and modulating brain plasticity occurring as a consequence of a SCI is a key factor in shaping clinically valuable top-down rehabilitation strategies that target the recovery of sensorimotor function in patients with SCI. To ground such vision, the researchers will use a goal-oriented action imagery training which is controlled and objectified by a BCI as a means to engage sensorimotor system and thus to facilitate neuroplasticity and optimize functional recovery in SCI during the subacute phase in which brain and spinal plasticity is at its climax.
In this study researchers will test the superiority of a BCI-assisted MI training (up to 12 weeks duration) with respect to MI practiced without BCI feedback (similar training setting and duration) to promote recovery of sensorimotor functions in traumatic cervical SCI subjects. The main hypothesis is that establishing a real-time contingency between the content of MI and an ecological feedback specifically designed to train MI in SCI patients will boost the effect of MI training in engaging the sensorimotor system. Primary and secondary outcome measures (reported in the dedicated section) include the most commonly used clinical and functional scales to assess SCI patients recovery. Neurophysiological and Neuroimaging outcomes are reported as other outcome measures in the dedicated session. Neuropsychological evaluation will include Test of Attentional Performance (TAP), Stroop Test, Trail Making Test (TMT), assessment of depression and anxiety; body ownership and representation. Furthermore, motivation, satisfaction, workload and usability will be evaluated along training.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →I.R.C.C.S. Fondazione Santa Lucia is the lead sponsor of 56 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
(EEG-)BCI- assisted MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).
Other: EEG-based BCI system for (hands) Motor Imagery training
MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).
Other: Control - MI intervention
For the purposes of this study we adapted an available BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback and a screen for the real-time ecological feedback to patient - a custom software program that provides a for (personalized) visual representation of the patient's own hands. This software allows the therapists to create an artificial reproduction of patient's hands/forearms by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hands/forearms. Training consists of the MI tasks of both hands, grasping or finger extension in separate runs. The trial length will include a constant baseline period of 4 sec and a task period of maximally 10 sec for BCI intervention group. Each training session will consist of 4 runs (20 trials each).
Also known as: BCI - EXP
Training consists of MI tasks of both hands, grasping or finger extension in separate runs. MI training will be delivered with a dose/setting regimen equivalent to EXP intervention. The trial length will include a constant baseline period of 4 sec and a task period of maximally 4 sec. Each training session will consist of 4 runs (20 trials each).
Also known as: MI - CTRL
Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory scores of bilateral arms at end of intervention
The GRASSP scale (somatosensory sub-section) ranges from 0 (maximum impairment) to 12 (normal) for each side arm.
Time frame: Pre-Randomization, Post Training (within 48 hours)
Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) motor scores of bilateral arms at end of intervention
The GRASSP scale (motor sub-section) ranges from 0 (maximum impairment) to 50 (normal) for each side arm.
Time frame: Pre-Randomization, Post Training (within 48 hours)
Mean change from baseline in the Spinal Cord Injury Independence Measure (SCIM) - self care section
The SCIM is the most commonly used independence scale for SCI patients. The Self Care section includes questions on feeding, grooming, bathing and dressing ranging from 0 (dependence) to 20 (independence).
Time frame: Pre-Randomization, Post Training (within 48 hours)
Mean change in Pain as assessed by the International SCI Pain Basic Dataset (ISCIPBDS)
The ISCIPBDS assesses pain in SCI patients. The questions concern pain severity, physical and emotional function and include a pain-intensity rating, a pain classification and questions related to the temporal pattern of pain for each specific pain problem. The impact of pain on physical, social and emotional function, and sleep is evaluated for each pain. Each question ranges from 0 to 10.
Time frame: Pre-Randomization, Post Training (within 48 hours)
Mean change in Upper Extremity Motor Score (UEMS) from the ISNCSCI AIS evaluation
The UEMS of the AIS assessment evaluates residual strength in upper limb segments and ranges from 0 to 50 (for both arms)
Time frame: Pre-Randomization, Post Training (within 48 hours)
Changes from baseline on high density Electroencephalography (hdEEG) patterns of cortical oscillatory activity and connectivity at end of intervention.
EEG recordings (motor relevant oscillatory activity and functional connectivity at rest and task related) to evaluate the neurophysiological substrates of the experimental intervention efficacy, in both BCI-based and Control intervention groups at end of treatment.
Time frame: Pre-Randomization, Post Training (within 1 week)
Changes in Motor Evoked Potentials (MEPs)
MEPs elicited via Transcranial Magnetic Stimulation (TMS) to evaluate the integrity of the Cortico Spinal Tract (CST) in both experimental and Control groups as factor influencing experimental intervention response
Time frame: Pre-Randomization, Post Training (within 1 week)
Changes in Somatosensory Evoked Potentials (SSEPs)
SSEPs from upper and lower limb nerves and recorded at peripheral and central stations via surface electrodes.
Time frame: Pre-Randomization, Post Training (within 1 week)
Structural Magnetic Resonance Imaging (MRI) of the whole brain and spinal cord
structural MRI to evaluate lesion size/site at the spinal cord level and cortico-spinal tract integrity in both experimental and Control groups as factor influencing experimental intervention response
Time frame: Pre-Randomization, Post Training (within 1 week)
Plan to share: No — Clinical, Neurophysiological, Neuropsychological and Neuroimaging Data will eventually be shared upon reasonable request (anonymized)
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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I.R.C.C.S. Fondazione Santa Lucia