Status:
COMPLETED
Testosterone and Long Pulse Stimulation After SCI
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Hunter Holmes McGuire VA Medical Center
Conditions:
Spinal Cord Injury
Eligibility:
MALE
18-70 years
Phase:
PHASE2
Brief Summary
Denervation following spinal cord injury (SCI) limits beneficial application of neuromuscular electrical stimulation (NMES). SCI with denervation results in extensive muscle atrophy that is accompanie...
Detailed Description
The long-term goal is to develop a rehabilitation strategy to mitigate the deleterious changes in muscle size and lower leg lean mass in persons with denervation following spinal cord injury (SCI). Cu...
Eligibility Criteria
Inclusion
- Traumatic motor complete SCI and level of injury of T10 and below
- Only participants with lower motor neuron (LMN) denervation as determined by EMG testing
- Participants must also have an absence of reflexes, denervation of both knee extensor muscles
- Tolerance to LPWS paradigm
- Both knee extensors will also have to be unresponsive (i.e., no observed tetanic contraction or twitches) to standard electrical stimulation procedures (stimulation frequency: 30 Hz; pulse duration:450 s and amplitude of the current:200 mA)
- All participants will undergo International Standards for Neurological Classification of SCI (ISNCSCI) examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury)
Exclusion
- Diagnosis of neurological injury other than SCI
- Pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II DM and those on insulin requirements) or other concurrent medical conditions judged to be contraindicated by the site physician.
- Hematocrit above 50% and severe urinary tract infection or symptoms
- Those with hyper-physiological testosterone level above 800 ng/dl
- Those who will fail to tolerate the LPWS paradigm
- Progressive condition that would be expected to result in changing neurological status
- Lower extremity fracture around the knee joint (distal femur or proximal tibia) within the last 2 years from enrollment in the study
- Knee BMD \< 0.60 gm/cm2
- Total hip BMD T-scores \< -3.5
- Untreatable severe spasticity judged to be contraindicated by the site Physician
- Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg)
- Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more
- Psychopathology documentation in the medical record or history that may conflict with study objectives
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03345576
Start Date
July 1 2018
End Date
November 30 2023
Last Update
October 14 2025
Active Locations (1)
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1
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249-0001