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NCTID
Brief title
Sponsor
Design
Criteria
Status
Target enrollment
Study phase & design
Primary intervention type
Primary potential benefit
Outcome measure
Follow up
Start date
First posted
Location
NCT02673320Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal StenosisNantes University HospitalParallel 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
Recruiting72Not ApplicableSurgeryStanding/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 years01 July 201603 February 20168
NCT02611375Conditioning Neural Circuits to Improve Upper Extremity FunctionShepherd 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
Ended80NATechnologyArm/hand function
  • Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
  • Motor Evoked Potentials (MEPs)
  • Surface Electromyography (sEMG)
6 weeks09 February 201720 November 20151
NCT02574585Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord InjuryHospital 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
40PHASE2Biological/cell basedStanding/walking/mobility
  • American Spinal Injury Association Impairment Scale (AIS): International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
12 months01 December 201914 October 20150
NCT02574572Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord InjuryHospital 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
10PHASE1Biological/cell basedGeneral health
  • American Spinal Injury Association Impairment Scale (AIS): International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
12 months06 September 201714 October 20151
NCT02566850Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical EnvironmentEkso Bionics
  • Age 18 - 65 yrs
  • Level C1-S5
  • AIS A, B, C, D
  • All
  • have a body height between 152 and 193cm (5’-6’33 feet)
  • have a body weight of less than 100kg (<200 lbs)
  • have a prior experience or be willing to train on the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking. Participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures
Ended4NARehabilitationGeneral health
  • Adverse Events (AEs)
  • American Spinal Injury Association Impairment Scale (AIS): International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
  • Ashworth and Modified Ashworth Scale (MAS)
  • Bowel and bladder control
  • Spinal Cord Independence Measure (SCIM)
42 months01 January 201402 October 20151
NCT02564419Brain Machine Interface (BMI) in Subjects Living With QuadriplegiaUniversity of Miami
  • Age 22 - 50 yrs
  • Level C5-C6
  • AIS A, B
  • ≥ 6 months
Ended1NATechnologyArm/hand function
  • American Spinal Injury Association Impairment Scale (AIS): International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
  • Ashworth and Modified Ashworth Scale (MAS)
  • Short Form 36 (SF-36)
  • Spinal Cord Independence Measure (SCIM)
2 years01 November 201530 September 20151