Status:
COMPLETED
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Lead Sponsor:
NeuroEnabling Technologies, Inc.
Collaborating Sponsors:
University of California, Los Angeles
California Institute of Technology
Conditions:
Paralysis
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.
Detailed Description
This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. The inv...
Eligibility Criteria
Inclusion
- ASIA C
- Spinal cord injury 1 or more years prior
- Non progressive SCI at C7 or higher
- Half of key muscles below neurological level having a motor score of less than 2/5
- Ability to commit to home exercises and 12 week participation
- Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities
- Not dependent on ventilation support
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with upper extremity rehabilitation or testing activities
- No clinically significant depression or ongoing drug abuse
- Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 12 week study period
- No current anti-spasticity regimen
- Must not have received botox injections in the prior six months
- Be unable to use upper extremity for functional tasks
Exclusion
- Pregnancy
- No functional segmental reflexes below the lesion
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01906424
Start Date
April 1 2016
End Date
December 31 2016
Last Update
January 24 2017
Active Locations (2)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Strides SCI Functional Fitness
San Juan Capistrano, California, United States, 92675