Status:
COMPLETED
Spinal Cord Stimulation to Augment Activity Based Therapy
Lead Sponsor:
Shepherd Center, Atlanta GA
Collaborating Sponsors:
Foundation Wings For Life
Conditions:
Transcutaneous Spinal Stimulation
Walking
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, ...
Detailed Description
Involuntary muscle activity, often referred to as spasticity, is a common problem following spinal cord injury. Spasticity can be evoked by stimuli or occur spontaneously, and it can manifest as spasm...
Eligibility Criteria
Inclusion
- Ability and willingness to consent and/or authorize use of protected health information
- Be between 18-65 years of age
- Be enrolled in Spinal Cord Injury In-Patient or Day Program at the Shepherd Center
- Be eligible for locomotor training at the Shepherd Center
- Be able to take a step, with or without an assistive device
- Have a spinal cord injury, completed in-patient rehabilitation, and have been discharged to home
- Have at least mild "spasticity" affecting leg muscles
- You may participate if you use prescription medications, including baclofen for control of spasticity
Exclusion
- Inability or unwillingness to consent and/or authorization for use of protected health information
- Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Neurologic level at or below spinal level T12
- History of cardiovascular irregularities
- Problems with following instructions
- Orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
- Women who are pregnant, or who have reason to believe they are or may become pregnant due to unknown risks to the fetus associated with tcSCS
- Persons who have implanted stimulators/electronic devices of any type will be excluded due to unknown potential of tcSCS effects
- Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03240601
Start Date
July 1 2017
End Date
September 11 2019
Last Update
January 25 2022
Active Locations (1)
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1
Shepherd Center, Inc.
Atlanta, Georgia, United States, 30309