Recruiting
Phase 1
Phase 2

TRT & Electrical Stimulation

Sponsor:

Kessler Foundation

Code:

NCT02317640

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: Male

Age: 18 - 58

Healthy Volunteers: Not accepted

Interventions

Testosterone Gel applied by a pump

Stand Training

Electrical Stimulation

Study Details

Brief 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.

Conditions

Spinal Cord Injury

Study ID

NCT02317640

Start date

Mar 15, 2017

Status verified date

Aug, 2017

Completion date

Oct, 2022

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 58

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stand Training Alone

Standing training will be prescribed 3 days/week (1.5 hours/sessions) for 60 sessions. All individuals randomized to stand training will train with BWST with manual assistance and will undergo a stand evaluation. During the evaluation the participants will be placed on the treadmill in an upright position and suspended in a harness by an overhead cable (i.e. BWST). A trainer will be positioned to assist the participant while standing and to provide manual assistance if needed. The amount of BWS and level of assistance given for each body segment will be recorded. The BWS level at which the participant can independently support good standing posture will also be recorded. Standing time while on treadmill and overground will be recorded daily as part of the training sessions.

experimental: ST with placebo or testosterone

Stand Training as described above with Placebo or testosterone Gel applied by a pump. After a baseline testing period, TRT will begin in the treatment groups by application of a daily dose of 40.5 mg of testosterone or placebo gel. The gel is to be applied to the upper arms and shoulders and is absorbed and eliminated over the course of a day. To ensure proper dosing serum T concentration will be assessed at screening, baseline, 2 weeks, 1 month and 3 month time points. As such, follow-up with the participant will be necessary to determine the correct replacement dose of TRT, and adjustment of dose if needed, (i.e. 40.5 mg up to 81 mg of gel). If serum T levels are not within normal range at the 2 week time point, the dose will be increased in increments of 20.25 mg up to 81 mg.

experimental: ST with Placebo or Testosterone and ES

Stand Training described above with Placebo or testosterone gel applied by a pump. Electrical stimulation will be applied via bifurcated leads and self-adhesive reusable surface electrodes. The electrodes will be applied over the motor points (both legs) on the following muscles: gluteus maximus (GL), rectus femoris (RF), biceps femoris (BF), gastrocnemei (GC), and anterior tibialis (TA) of both legs. Two electrodes will be used for each muscle. One "RT300 portable stimulator" (Restorative Therapies, Inc., Baltimore, MD) will be used to induce the electrical stimulation with 10 sets of electrodes for stimulation.

experimental: ST with ES

Stand Training as described above in Stand Training alone and Electrical Stimulation as described above in ST with Placebo or Testosterone and ES.

Interventions

Testosterone Gel applied by a pump

After being diagnosed with low testosterone levels the participant will be given a 30-day supply of the Testosterone/placebo gel (40.5 mg/day). The gel is to be applied every morning on clean and dry area of skin of the upper arms and shoulders.

Stand Training

Stand training with BWST with manual assistance. Participant is placed on treadmill in an upright position and suspended in a harness by an overhead cable. A trainer will aid the participant in pelvis and trunk stabilization, by applying anterior forces at the pelvis and/or posterior forces at the shoulders and ensure that the trunk and pelvis are not flexed or hyper-extended.

Electrical Stimulation

Electrical Stimulation (ES) will be applied via bifurcated leads and self-adhesive reusable surface electrodes. The electrodes will be applied over the motor points of both legs. Two electrodes will be used for contracting each muscle.

Primary outcome measure

  • Muscle Volume (percent change in muscle volume for the bilateral thigh) [ Time Frame: 38 weeks ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

More Information

Sponsor

Kessler Foundation

Last update posted

Aug 22, 2017

Last verified

Aug, 2017

Keywords

  • Testosterone
  • Electrical Stimulation
  • Stand Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2017-08-22.