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

NCT02317640 | Unknown Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: DOD SC130243
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

Testosterone; Electrical Stimulation; Stand Training

Outcome Measures

Primary Outcomes (1)

• Muscle Volume (percent change in muscle volume for the bilateral thigh)

  Muscle volume will be measured in the thigh. The percent change in muscle volume for the bilateral thigh will be compared to before the intervention to after the intervention.

  38 weeks

Secondary Outcomes (2)

• Change in Muscle (increase in muscle torque)

  38 weeks

• Change in Bone (BMD of the proximal tibia and distal femur)

  38 Weeks

Study Arms (4)

Stand Training Alone

ACTIVE COMPARATOR

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.

Other: Stand Training

ST with placebo or testosterone

EXPERIMENTAL

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.

Drug: Testosterone Gel applied by a pump; Other: Stand Training

ST with Placebo or Testosterone and ES

EXPERIMENTAL

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.

Drug: Testosterone Gel applied by a pump; Other: Stand Training; Device: Electrical Stimulation

ST with ES

EXPERIMENTAL

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

Other: Stand Training; Device: Electrical Stimulation

Interventions

Testosterone Gel applied by a pump DRUG

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.

Also known as: Androgel 1.62%

ST with Placebo or Testosterone and ES; ST with placebo or testosterone

Stand Training OTHER

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.

Also known as: Locomotor Training

ST with ES; ST with Placebo or Testosterone and ES; ST with placebo or testosterone; Stand Training Alone

Electrical Stimulation DEVICE

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.

Also known as: ES

ST with ES; ST with Placebo or Testosterone and ES

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be a male between 18 and 58 years old;
• 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;
• Must be able to tolerate electrical stimulation and must show visible muscle contraction to an electrical stimulus;
• Must be wheelchair reliant for more than 75% of the time;
• Must have low testosterone levels (300-325 ng/dL) as determined by a blood test done at the baseline study visit.

You may not qualify if:

• 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.
• Less than 6 months or greater than 10 years post injury;
• A score \>3 on the Modified Ashworth Scale as determined by study staff;
• Bone density measurement for the knee is at or below .5755 gm/cm2 as recorded by study staff;
• Weigh more than 225 lbs;
• Taller than 6 feet 3 inches;
• Presence of a cardiovascular disease;
• Presence of pulmonary disease;
• Presence of recent lower limb fractures;
• Presence of severe contractures;
• Presence of lower extremity deep vein thrombosis (within the last three months) or other major medical illness;
• Taking medications known to influence bone metabolism as determined by study staff review of medications;
• A major gastrointestinal problem such as swallowing or gastrointestinal reflux disease;
• Heart rate or rhythm problems;
• A pacemaker;

Sponsors & Collaborators

• Kessler Foundation: lead
• United States Department of Defense: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Gail F Forrest, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail F Forrest, PhD

CONTACT

973-324-3518; gforrest@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2014
• First Posted: December 16, 2014
• Study Start: March 15, 2017
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)