Motor Recovery by Epidural stimulation after Spinal Cord Injury: A pilot clinical study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
| Spinal cord injury (SCI) is often a catastrophic condition requiring chronic care. Despite an enormous amount of research in SCI, the neurological prognosis for a patient with severe SCI remains dismal. Furthermore, majority of the patients with SCI are young, and the economic and societal impact is enormous, both to the immediate family and the society at large. Life expectancy after such an injury is markedly reduced due to complications proportional to the severity of injury or remaining neurologic functions. A number of surgical modalities are available for traumatic conditions of spine. Despite having good radiological results, their impact on socioeconomic status of an individual in developing nations poor. One of the reasons for such a condition is non-functional improvement in motor power after traumatic SCI surgery. |
Previous studies conducted in animal models, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. A few human studies in western world have shown epidural electrical stimulation of the lumbosacral spinal cord in spinal cord injury (SCI) was able to partially restore motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore motor and autonomic functions in patients with SCI.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in ASIA sensory examination(Any voluntary movement by additional muscle groups not included in ISNCSCI)