跳至主要内容
临床试验/NCT05637775
NCT05637775已完成不适用

DiSCIoser: Unlocking Recovery Potential of Arm Sensorimotor Functions After Spinal Cord Injury by Promoting Activity-dependent Brain Plasticity and Modeling the Causal Relationship Between Brain Plasticity and Recovery of Function

I.R.C.C.S. Fondazione Santa Lucia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory scores of bilateral arms at end of intervention

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors performing clinical evaluation and data analysts will be blinded to patient allocation.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

CTRL - MI

Active Comparator

MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

干预措施: Control - MI intervention (Other)

EXP - BCI

Experimental

(EEG-)BCI- assisted MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

干预措施: EEG-based BCI system for (hands) Motor Imagery training (Other)

结局指标

主要结局

Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory scores of bilateral arms at end of intervention

时间窗: 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.

次要结局

  • Mean change in Upper Extremity Motor Score (UEMS) from the ISNCSCI AIS evaluation(Pre-Randomization, Post Training (within 48 hours))
  • Mean change from baseline in the Spinal Cord Injury Independence Measure (SCIM) - self care section(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(Pre-Randomization, Post Training (within 48 hours))
  • Mean change in Pain as assessed by the International SCI Pain Basic Dataset (ISCIPBDS)(Pre-Randomization, Post Training (within 48 hours))

研究者

发起方
I.R.C.C.S. Fondazione Santa Lucia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Donatella Mattia

Professor, Laboratory Director

I.R.C.C.S. Fondazione Santa Lucia

研究点 (2)

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