New combo therapy aims to restore muscle in paralyzed legs

NCT ID NCT03345576

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jul 2018

Finished

Nov 2023

Lead sponsor

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

18 to 70 years

Sex

Male participants only

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Spinal cord injury are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • 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.