Health Condition 1: S220- Fracture of thoracic vertebra
Conditions
Interventions
Intervention1: Epidural Stimulation: Subjects will be implanted with an epidural stimulator once for continuous stimulation onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients w
Sponsors
Indian Spinal Injuries Center
Eligibility
Inclusion criteria
Inclusion criteria: Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with body weight support training No current anti-spasticity medication regimen Non-progressive spinal cord injury between the vertebral levels of C5 & T12 American Spinal Injury Association grading scale of A/B/C Sensory evoked potentials are either not present or have a bilateral delay At least 6 months post-injury
Exclusion criteria
Exclusion criteria: Pregnancy at the time of enrollment Failure to obtain consent Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with a stand or step training Current anti-spasticity medication regimen Implanted cardiac pacemaker Implanted defibrillator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1,Improvement in the AIS of at least one grade (for example, conversion from AIS A to AIS B or better) or a change from baseline of 6 points in total ASIA motor score. Timepoint: 1,Improvement in the AIS of at least one grade (for example, conversion from AIS A to AIS B or better) or a change from baseline of 6 points in total ASIA motor score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ASIA sensory examination Any voluntary movement by additional muscle groups not included in ISNCSCI Walking Index of Spinal Cord Injury (WISCI) Modified Ashworth Spasticity Scale Spinal Cord Independence Measure (SCIM) Psychological evaluation by Beck Depression Inventory (BDI) Electromyography (EMG), nerve conduction velocity (NCV), somatosensory evoked potential (SSEP) and motor-evoked Potential (MEP), Urodynamic study International Spinal Cord Injury Scale (ISCIS)Timepoint: two years | — |
Countries
India
Contacts
Public ContactDrKalyan Kumar Varma
indian spinal injuries center
Outcome results
None listed