| NCT02799966 | Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study | University of British Columbia | | - Age ≥ 18 yrs
- Level C4-C7
AIS B, C, D- ≥ 10 days
- have had a spinal cord injury for at least 10 days.
- have a neurological injury level in the neck, between C4 and C7.
- ASIA impairment scale (AIS) is one of the following:
- AIS B: incomplete; have feeling, but no movement, below injury level
- AIS C: incomplete; at least some feeling and mostly weak movement below injury
- AIS D: incomplete; at least some feeling and, some weak but mostly stronger movement below injury
- be at least 18 years of age.
- NOT have other implanted device, e.g. pacemaker
| Ended | 9 | NA | Technology | Arm/hand function | - Action Research Arm Test (ARAT)
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
- Spinal Cord Independence Measure (SCIM)
- Toronto Rehabilitation Institute Hand Function Test
| 7 weeks | 12 December 2017 | 15 June 2016 | 3 | |
| NCT02688049 | NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair | Chinese Academy of Sciences | | - Age 18 - 65 yrs
- Level C5-T12
AIS A- All
- have a chronic spinal cord injury
- have a neurological level of injury between C5 and Th12
- have the following ASIA impairment scale (AIS) classifications:
- AIS A: complete; no feeling or movement below the injury with no evidence of further improvement.
- be between 18 and 65 years of age
- be able and willing to attend scheduled follow-up visits over 24 months at the study center (Tianjin, China).
| | 30 | PHASE1, PHASE2 | Biological/cell based | Arm/hand function | - Adverse Events (AEs)
- American Spinal Injury Association Impairment Scale (AIS)
- Bowel and bladder control
- Functional Independence Measure (FIM)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
- Magnetic Resonance Imaging (MRI) - conventional/anatomical and quantitative
- Motor Evoked Potentials (MEPs)
- Sensory evoked potentials (including mixed and dermatomal, mSSEPs, dSSEPs, contact heat/laser evoked potentials- CHEPS/LEPs)
| 24 months | 01 January 2016 | 23 February 2016 | 1 | |
| NCT02673320 | Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis | Nantes University Hospital | Parallel Assignment | - Age ≥ 18 yrs
- Level C1-T1
AIS A, B, C, D- ≤ 15 days
- have an acute spinal cord injury capable of undergoing surgical decompression within 48 hours at the time of randomization.
- have a neurological level of injury between C2-T1
- have one of the following ASIA impairment scale (AIS):
- AIS A: complete; no feeling or movement below the injury
- AIS B: incomplete; have some feeling, but no movement, below the injury
- AIS C: incomplete; at least some feeling and mostly weak movement below the injury
- AIS D: incomplete; at least some feeling and, some weak but mostly stronger movement below the injury
- be at least 18 years of age
- be able to undergo an MRI
| Recruiting | 72 | Not Applicable | Surgery | Standing/walking/mobility | - American Spinal Injury Association Impairment Scale (AIS)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
- Pain Visual Analog Scale (VAS)
- Short Form 36 (SF-36)
- Spinal Cord Independence Measure (SCIM)
- Walking Index for Spinal Cord Injury (WISCI) and WISCI II
| 2 years | 01 July 2016 | 03 February 2016 | 8 | |
| NCT02611375 | Conditioning Neural Circuits to Improve Upper Extremity Function | Shepherd Center, Atlanta GA | | - Age 18 - 65 yrs
- Level C1-C8
AIS A, B, C, D- All
- must have some trouble moving at least one of your arms/hands.
- must be able to pick up an object with at least one hand without any type of help.
- be able to lift one arm up to chest level.
- NOT have other implanted device, e.g. pacemaker
- NOT have history of epilepsy or severe headaches
| Ended | 80 | NA | Technology | Arm/hand function | - Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
- Motor Evoked Potentials (MEPs)
- Surface Electromyography (sEMG)
| 6 weeks | 09 February 2017 | 20 November 2015 | 1 | |
| NCT02574585 | Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury | Hospital Sao Rafael | | - Age 18 - 65 yrs
- Level T1-L2
AIS A- ≥ 12 months
- NOT have diabetes mellitus type 1 or 2
- NOT have SCI due to sharp object or firearm
- NOT have other metallic implant that would affect MRI
| | 40 | PHASE2 | Biological/cell based | Standing/walking/mobility | - American Spinal Injury Association Impairment Scale (AIS)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
| 12 months | 01 December 2019 | 14 October 2015 | 0 | |
| NCT02574572 | Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury | Hospital Sao Rafael | | - Age 18 - 65 yrs
- Level C5-C7
AIS A- ≥ 12 months
- have a spinal cord injury for at least 12 months
- have a neurological level of injury between C5 and C7
- have the following ASIA impairment scale (AIS) grade:
- AIS A: complete; no feeling or movement below the injury
- be between 18 and 65 years of age
- NOT have penetrating injury, e.g. gunshot or knife wound
- NOT have other device implanted that would affect MRI, e.g. pacemaker
| | 10 | PHASE1 | Biological/cell based | General health | - American Spinal Injury Association Impairment Scale (AIS)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
| 12 months | 06 September 2017 | 14 October 2015 | 1 | |
