New combo therapy aims to restore muscle in paralyzed legs
NCT ID NCT03345576
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether combining testosterone therapy with a special type of electrical stimulation (long pulse width) could rebuild leg muscle in 12 people with spinal cord injury whose muscles no longer respond to standard electrical stimulation. Participants received supervised training for one year. The study measured changes in muscle size using MRI and looked at how the muscles' energy centers (mitochondria) responded. The goal is to find a way to improve muscle health and reduce related health risks in people with denervated muscles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- testosterone replacement therapy and long pulse width electrical stimulation
- What this could lead to
- If it works, this could offer a way to restore leg muscle size and improve metabolic health in people with spinal cord injury who have lost nerve connection to their muscles.
- What could go wrong
- This is a small, early-phase trial with only 12 participants, so results may not apply to everyone. The combination therapy is complex and may not produce lasting benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
12 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Nov 2023
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Traumatic motor complete SCI and level of injury of T10 and below * Only participants with lower motor neuron (LMN) denervation as determined by EMG testing * Participants must also have an absence of reflexes, denervation of both knee extensor muscles * Tolerance to LPWS paradigm * Both knee extensors will also have to be unresponsive (i.e., no observed tetanic contraction or twitches) to standard electrical stimulation procedures (stimulation frequency: 30 Hz; pulse duration:450 s and amplitude of the current:200 mA) * All participants will undergo International Standards for Neurological Classification of SCI (ISNCSCI) examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) Exclusion Criteria: * Diagnosis of neurological injury other than SCI * Pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II DM and those on insulin requirements) or other concurrent medical conditions judged to be contraindicated by the site physician. * Hematocrit above 50% and severe urinary tract infection or symptoms * Those with hyper-physiological testosterone level above 800 ng/dl * Those who will fail to tolerate the LPWS paradigm * Progressive condition that would be expected to result in changing neurological status * Lower extremity fracture around the knee joint (distal femur or proximal tibia) within the last 2 years from enrollment in the study * Knee BMD \< 0.60 gm/cm2 * Total hip BMD T-scores \< -3.5 * Untreatable severe spasticity judged to be contraindicated by the site Physician * Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg) * Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more * Psychopathology documentation in the medical record or history that may conflict with study objectives
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Determination of efficacy of sustained motor contraction generated using StimWave peripheral nerve stimulator
- Can magnetic pulses to the brain restore hand control after spinal injury?
- Robotic legs may help rebuild bone in people with spinal cord injury
- Could a muscle hormone shield bones after spinal cord injury?
- Can hope and trust boost engagement with rehab robots?
- Spinal zaps may calm muscle spasms after injury