Status:
COMPLETED
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
Lead Sponsor:
Shepherd Center, Atlanta GA
Collaborating Sponsors:
Emory University
Conditions:
Spinal Cord Injuries
Spasticity, Muscle
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the quality of life of people with spinal cord injury (SCI). In people with spinal cord injury, spasticity can li...
Detailed Description
Involuntary muscle activation, also referred to as spasticity is a common characteristic of spinal cord injuries. It can present as stiffness, clonus, and spasms that can impact a person's ability to ...
Eligibility Criteria
Inclusion
- Be 18-65 years of age
- Have sustained cervical or thoracic SCI at least 6 months prior to initiating participation in study
- Any ISNCSCI severity classification (A, B, C, or D)
- Have self-reported spasticity and at the time of screening demonstrate an FSE angle of ≤ 75 degrees on the pendulum test or ≥ 4 beats of clonus on the drop test
- May participate if utilizing oral prescription medications for control of spasticity
- Ability and willingness to consent and authorize use of personal health information
Exclusion
- Severe contractures of the leg/foot to be stimulated (decided during pre-assessment) that limit passive movement of the hip, knee, or ankle more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
- Any implanted catheter such as but not limited to CSF shunt, baclofen pump, or the presence of a pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions)
- Severe pain or hypersensitivity of the leg to be stimulated (decided during pre-assessment)
- Uncontrolled edema of the leg to be stimulated (decided during pre-assessment)
- Current pregnancy
- Lumbar spinal cord injury level
- Inability or unwillingness to consent and authorize use of personal health information
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04130295
Start Date
October 15 2019
End Date
March 25 2021
Last Update
July 27 2021
Active Locations (1)
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1
Shepherd Center
Atlanta, Georgia, United States, 30309