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Locomotor Training + Testosterone for Spinal Cord Injury
Study Summary
This trial will study the feasibility of using testosterone replacement therapy along with locomotor training to improve walking function in men with spinal cord injuries and low testosterone levels.
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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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- Men who are older than 18 years.Your testosterone levels are too low.For men, your PSA level is higher than 3.0 ng/mL, unless you are taking certain medications and your PSA level is 1.5 ng/mL or less.You have a heart rhythm problem that is not well controlled.Your liver enzymes (AST or ALT) are more than 1.5 times the normal level.You are allergic to any ingredient in the TRT formulation, like sesame oil or cottonseed oil.You have a serious problem with one of your heart valves.You are not expected to live for more than 12 months.You have a spinal condition that could make it difficult to participate in the study.You have conditions like multiple sclerosis, amyotrophic lateral sclerosis, or other nervous system problems.You have prostate, breast, or any other type of cancer now or in the past.You have been diagnosed or treated for any other type of cancer within the past 24 months, except for certain types of skin cancer that have been successfully treated.You have a lump or hard area in your prostate found during a rectal exam that could be a sign of prostate cancer.You have enlarged male breasts.Your hematocrit level is higher than 49%.You had a serious heart or blood vessel problem in the past year, like a heart attack, needing a procedure to open blocked arteries, or being hospitalized for certain heart or blood vessel conditions.You have severe or uncontrolled chest pain despite taking medication.You have severe congestive heart failure that is not well controlled.Your high blood pressure is not well controlled even with medication.Your initial ECG shows certain unusual patterns that would make it difficult to check for hidden heart problems in the future.You have had blood clots in your veins for no clear reason, or have a history of recurring blood clots, or have a known condition that increases the risk of blood clot formation.Your "bad" cholesterol (LDL) is higher than 160 mg/dL and you have had a major heart-related event in the past year.You have very severe chronic kidney disease with a specific test showing a low kidney function.You have severe sleep apnea that hasn't been treated yet.You have had a leg bone break in the past year and want to participate in the LT+TRT group.Your bone density test shows that your bones are too weak.You are currently taking medication that prevents blood clotting and cannot receive injections in the muscle.You have used certain medications related to hormones or growth in the last 90 days.You have taken medications for bone health in the last 6 months.You have taken certain pain medications or steroids for more than a few days in the past week, unless you need them for a long-term condition.You have a spinal cord injury involving certain spinal segments and have been showing certain signs for more than 60 days.You have trouble walking at a regular speed, even with the help of devices or assistance.You have signs or symptoms related to low testosterone, such as reduced sexual desire, erectile dysfunction, decreased energy, or other related issues.You have a first-time spinal cord injury caused by trauma, vascular issues, or orthopedic problems.
- Group 1: testosterone enanthate
- Group 2: locomotor training, testosterone enanthate
- Group 3: non-interventional control
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any available openings for participants in this trial?
"The information available on clinicaltrials.gov verifies that this study is still seeking patients for participation. The listing was created on 1/31/2021, with the most recent update taking place on 9/26/2022. Two medical facilities are looking to enrol a total of 21 individuals."
How many people are included in this medical study?
"Yes, you're right. The clinical trial aforementioned is looking for 21 individuals from 2 sites. The listing was created on 1/31/2021 and updated as recently as 9/26/2022 according to information found on clinicaltrials.gov"
Is Locomotor Training a safe way for people to get around?
"Locomotor Training received a 2 on our team's safety scale at Power. This is because, while there are Phase 2 trials supporting the intervention's safety, there is no data currently backing up its efficacy."
What are the researchers' goals for this clinical trial?
"The primary outcome being tracked in this medical study is a change in the 6 min walk test (6MWT) score, with observations taking place at the start of the trial and then 3 and 6 months later. Additionally, researchers will be looking for changes in 10mWT time, bone resorption marker levels, and knee extensor peak torque as secondary outcomes over the course of the clinical trial."
Are there previous examples of Locomotor Training being used in a medical capacity?
"There are six separate clinical trials currently underway to research locomotor training. Of these, none have reached phase 3 yet. The majority of the studies are taking place in Galveston, Texas; however, there are seven research centres in total running these tests."
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