Spinal Cord Injuries Clinical Trial
— DiSCIoserOfficial title:
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
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
I.R.C.C.S. Fondazione Santa Lucia | University of Roma La Sapienza |
Italy,
Brown AR, Martinez M. From cortex to cord: motor circuit plasticity after spinal cord injury. Neural Regen Res. 2019 Dec;14(12):2054-2062. doi: 10.4103/1673-5374.262572. — View Citation
Donati AR, Shokur S, Morya E, Campos DS, Moioli RC, Gitti CM, Augusto PB, Tripodi S, Pires CG, Pereira GA, Brasil FL, Gallo S, Lin AA, Takigami AK, Aratanha MA, Joshi S, Bleuler H, Cheng G, Rudolph A, Nicolelis MA. Long-Term Training with a Brain-Machine Interface-Based Gait Protocol Induces Partial Neurological Recovery in Paraplegic Patients. Sci Rep. 2016 Aug 11;6:30383. doi: 10.1038/srep30383. — View Citation
Mattia D, Pichiorri F, Colamarino E, Masciullo M, Morone G, Toppi J, Pisotta I, Tamburella F, Lorusso M, Paolucci S, Puopolo M, Cincotti F, Molinari M. The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response. BMC Neurol. 2020 Jun 27;20(1):254. doi: 10.1186/s12883-020-01826-w. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Pre-Randomization, Post Training (within 1 week) | |
Other | 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 | Pre-Randomization, Post Training (within 1 week) | |
Other | Changes in Somatosensory Evoked Potentials (SSEPs) | SSEPs from upper and lower limb nerves and recorded at peripheral and central stations via surface electrodes. | Pre-Randomization, Post Training (within 1 week) | |
Other | 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 | Pre-Randomization, Post Training (within 1 week) | |
Primary | 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. | Pre-Randomization, Post Training (within 48 hours) | |
Secondary | 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. | Pre-Randomization, Post Training (within 48 hours) | |
Secondary | 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). | Pre-Randomization, Post Training (within 48 hours) | |
Secondary | 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. | Pre-Randomization, Post Training (within 48 hours) | |
Secondary | 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) | Pre-Randomization, Post Training (within 48 hours) |
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