DiSCIoser: Improving Arm Sensorimotor Functions After Spinal Cord Injury Via Brain-Computer Interface Training

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Motor Disorders
• Interventions: Other: Control - MI intervention; Other: EEG-based BCI system for (hands) Motor Imagery training

• Registration Number: NCT05637775
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• subacute cervical SCI (30-90 days from event)
• classification according to ISNCSCI AIS A-D, lesion level C1-T1
• Upper Extremity Motor Score (UEMS) < 40

Exclusion Criteria

• other conditions (present or previous) potentially affecting sensorimotor upper limb function
• inability to give informed consent and understand the requirements for the training

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTRL - MI	Control - MI intervention	MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).
EXP - BCI	EEG-based BCI system for (hands) Motor Imagery training	(EEG-)BCI- assisted MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

Primary Outcome Measures

Name	Time	Method
Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory scores of bilateral arms at end of intervention	Pre-Randomization, Post Training (within 48 hours)	The GRASSP scale (somatosensory sub-section) ranges from 0 (maximum impairment) to 12 (normal) for each side arm.

Secondary Outcome Measures

Name	Time	Method
Mean change in Upper Extremity Motor Score (UEMS) from the ISNCSCI AIS evaluation	Pre-Randomization, Post Training (within 48 hours)	The UEMS of the AIS assessment evaluates residual strength in upper limb segments and ranges from 0 to 50 (for both arms)
Mean change from baseline in the Spinal Cord Injury Independence Measure (SCIM) - self care section	Pre-Randomization, Post Training (within 48 hours)	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).
Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) motor scores of bilateral arms at end of intervention	Pre-Randomization, Post Training (within 48 hours)	The GRASSP scale (motor sub-section) ranges from 0 (maximum impairment) to 50 (normal) for each side arm.
Mean change in Pain as assessed by the International SCI Pain Basic Dataset (ISCIPBDS)	Pre-Randomization, Post Training (within 48 hours)	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.

Trial Locations

Locations (1)

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS; 🇮🇹 Rome, Italy