TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to understand what happens to muscle and bone in spinal cord injured males after four months of training using stand training, with body weight support (BWS), with testosterone replacement therapy (TRT), and electrical stimulation (ES). Specifically, researchers will investigate nerve, muscle, and bone changes in the lower limbs in response to stand training and ES when combined with TRT compared to i) standing alone with TRT; ii) stand training alone with placebo; iii) stand training alone and ES with placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kessler Foundation
• Collaborator: United States Department of Defense
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. Must be a male between 18 and 58 years old;

2. Must have a spinal cord injury at a neurological level of injury between the C6-T10 level and an impairment grade A, B, or C, according to the American Spinal Injury Association (ASIA) Impairment Scale. If a person with quadriplegia their motor level will be used instead of neurological level. As a quadraplegic the motor level must be between C6-T10;

3. Must be able to tolerate electrical stimulation and must show visible muscle contraction to an electrical stimulus;

4. Must be wheelchair reliant for more than 75% of the time;

5. Must have low testosterone levels (300-325 ng/dL) as determined by a blood test done at the baseline study visit.

Exclusion Criteria:

1. Taking spasticity medication (i.e., baclofen). It may be possible that participant can be weaned off of the spasticity medication prior to starting entry into the study. This would be under the guidance of the study physician.

2. Less than 6 months or greater than 10 years post injury;

3. A score >3 on the Modified Ashworth Scale as determined by study staff;

4. Bone density measurement for the knee is at or below .5755 gm/cm2 as recorded by study staff;

5. Weigh more than 225 lbs;

6. Taller than 6 feet 3 inches;

7. Presence of a cardiovascular disease;

8. Presence of pulmonary disease;

9. Presence of recent lower limb fractures;

10. Presence of severe contractures;

11. Presence of lower extremity deep vein thrombosis (within the last three months) or other major medical illness;

12. Taking medications known to influence bone metabolism as determined by study staff review of medications;

13. A major gastrointestinal problem such as swallowing or gastrointestinal reflux disease;

14. Heart rate or rhythm problems;

15. A pacemaker;

16. Had spinal fusion, must have approval from the referring physician to receive ES - assisted standing prior to acceptance into the study;

17. As determined by study staff and review of medications, taking medication known to affect my level of testosterone;

18. A PSA greater than or equal to 4.0 ng/ml as determined by blood tests during screening visit;

19. An elevated PSA or asymmetry or hardening of prostate as determined by blood tests and digital rectal examination at screening visit.

20. Any known heart or blood vessel problems (cardiovascular disease)

21. An acute illness of any cause;

22. History of anabolic steroid use as determined by study staff review of participant's medical records;

23. Have a hematocrit greater than or equal to 55 as measured by the study team.

24. Have an abnormal liver function test from the hepatic panel (greater than 2.5 times the normal value) as measured by the study team;

25. Have an abnormal digital rectal exam (DRE) at baseline suggestive of malignancy;

26. Currently abuse alcohol or drugs;

27. Have a significant psychological disorder;

28. Have a history of or a current malignancy;

29. Wish to contribute to the conception of a child.

If any of the following occurs in the experimental group following initiation of testosterone replacement therapy participation will be terminated.

1. Hematocrit greater than or equal to 55;

2. Abnormal liver function test from the hepatic panel (greater than 2.5 times the normal value);

3. Worsening of any sleep disorder, as determined by the Investigators;

4. A PSA greater than or equal to 4.0 ng/ml;

5. Worsening of mood disorders; i.e. anger and depression as determined by the investigators;

6. Planning to contribute to the conception of a child during the study period.

7. Have participated in an electrical stimulation or TRT study in the previous 3 months.