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Testosterone + LPWS and Testosterone + NMES for Spinal Cord Injury
Study 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.
- Spinal Cord Injury
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Testosterone and LPWS
- Group 2: Testosterone and standard NMES
- 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.
Frequently Asked Questions
What is the capacity of participants accepted into this research endeavor?
"Affirmative. The information available on clinicaltrials.gov attests that this medical experiment, first published on July 1st 2018, is presently recruiting participants. 24 individuals need to be enrolled from a single research centre."
Does the FDA recognize Testosterone and LPWS as safe treatments?
"Taking into consideration the stage of development for Testosterone and LPWS, our team at Power rated their safety as a 2. This is indicative that while there are certain datapoints surrounding safety, efficacy has yet to be demonstrated."
Who is deemed an ideal candidate for this trial?
"This trial seeks individuals who have experienced spinal cord injuries and are of legal age, between 18-70 years old. The study is looking to enrol 24 patients in total."
Are there any vacancies for participants in this trial?
"As evidenced on clinicaltrials.gov, the study is actively recruiting participants since it was first posted on July 1st 2018 and recently updated April 5th 2022."
Could you please provide details about prior investigations related to Testosterone and LPWS?
"Currently, 29 trials examining the efficacy of Testosterone and LPWS are running. Of these experiments, 5 have graduated to Phase 3 testing. Although many of the studies connected to this treatment are based in Houston, Texas, there is a total of 124 research centres conducting such tests around the nation."
What are the typical indications for Testosterone and LPWS treatment?
"Testosterone and LPWS have demonstrated efficacy in treating hypogonadotropic hypogonadism, as well as post-menopausal conditions that occur within the span of 1 to 5 years. These treatments are also commonly prescribed for orchidectomy and orchitis patients."
Does this research endeavor open to younger participants under 25 years old?
"This study specifies that applicants aged 18 to 70 are eligible. Additionally, there exist 37 trials for individuals under the age of majority and 326 studies dedicated to those over pensionable age."
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