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Testosterone + LPWS and Testosterone + NMES for Spinal Cord Injury
Phase 2
Waitlist Available
Led By Ashraf Gorgey, PhD PT
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial will study the effects of long pulse width stimulation (LPWS) and testosterone replacement therapy (TRT) on restoring muscle size and leg lean mass after denervation in persons with SCI.
Eligible Conditions
- Spinal Cord Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Muscle Size Change
Secondary outcome measures
Basal Metabolic Rate
Mitochondrial enzymatic activities
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Testosterone and LPWSExperimental Treatment1 Intervention
Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and long pulse width stimulation (LPWS) in persons with denervated spinal cord injury.
Group II: Testosterone and standard NMESPlacebo Group1 Intervention
Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and standard surface neuromuscular electrical stimulation (NMES) in persons with denervated spinal cord injury.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone and LPWS
2018
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,967 Total Patients Enrolled
Hunter Holmes McGuire VA Medical CenterFED
10 Previous Clinical Trials
1,211 Total Patients Enrolled
Ashraf Gorgey, PhD PTPrincipal InvestigatorHunter Holmes McGuire VA Medical Center, Richmond, VA
2 Previous Clinical Trials
36 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot handle the LPWS program.You have a condition that is getting worse and may affect your brain and nerves.Your hip bone density score is very low.Your knee muscles don't respond to regular electrical stimulation.You have had a specific neurological examination and have been classified with a certain type of spinal cord injury.Your testosterone level is higher than 800 ng/dl.Your knee bone density is lower than 0.60 gm/cm2.You have severe spasticity that cannot be treated by the site physician.You have broken a bone around your knee in the past 2 years.You have a neurological injury other than spinal cord injury.You have certain medical conditions like heart problems or uncontrolled type 2 diabetes that your doctor thinks could make it unsafe for you to participate.Your blood is too thick (hematocrit above 50%) and you have a severe urinary tract infection or symptoms.You have high blood pressure that has not been treated or is not under control.You have a severe pressure sore in certain areas of your body.You have a complete spinal cord injury from a traumatic accident, and the injury is at level T10 or below.You don’t have reflexes and your knee muscles are weak.Ability to tolerate LPWS paradigmYou have nerve damage in your muscles, as shown by a specific test called EMG.You should not have knee reflexes and your knee extensor muscles should show signs of nerve damage.Everyone will have a neurological exam to check their spinal cord function. Only those with a specific type of motor deficit below the spinal injury level will be included.Both knee muscles don't respond to standard electrical stimulation.
Research Study Groups:
This trial has the following groups:- Group 1: Testosterone and LPWS
- Group 2: Testosterone and standard NMES
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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