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Procedure

Testosterone + LPWS and Testosterone + NMES for Spinal Cord Injury

Phase 2
Waitlist Available
Led By Ashraf Gorgey, PhD PT
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresponsiveness of both knee extensors to standard electrical stimulation procedures
Undergo International Standards for Neurological Classification of SCI (ISNCSCI) examination and have American Spinal Injury Classification (AIS A and B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study the effects of long pulse width stimulation (LPWS) and testosterone replacement therapy (TRT) on restoring muscle size and leg lean mass after denervation in persons with SCI.

Eligible Conditions
  • Spinal Cord Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your knee muscles don't respond to regular electrical stimulation.
Select...
You have had a specific neurological examination and have been classified with a certain type of spinal cord injury.
Select...
You have a complete spinal cord injury from a traumatic accident, and the injury is at level T10 or below.
Select...
You don’t have reflexes and your knee muscles are weak.
Select...
Ability to tolerate LPWS paradigm

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle Size Change
Secondary outcome measures
Basal Metabolic Rate
Mitochondrial enzymatic activities

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Testosterone and LPWSExperimental Treatment1 Intervention
Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and long pulse width stimulation (LPWS) in persons with denervated spinal cord injury.
Group II: Testosterone and standard NMESPlacebo Group1 Intervention
Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and standard surface neuromuscular electrical stimulation (NMES) in persons with denervated spinal cord injury.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone and LPWS
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,600 Previous Clinical Trials
3,305,111 Total Patients Enrolled
Hunter Holmes McGuire VA Medical CenterFED
10 Previous Clinical Trials
1,211 Total Patients Enrolled
Ashraf Gorgey, PhD PTPrincipal InvestigatorHunter Holmes McGuire VA Medical Center, Richmond, VA
2 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Long Pulse Width Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03345576 — Phase 2
Spinal Cord Injury Research Study Groups: Testosterone and LPWS, Testosterone and standard NMES
Spinal Cord Injury Clinical Trial 2023: Long Pulse Width Stimulation Highlights & Side Effects. Trial Name: NCT03345576 — Phase 2
Long Pulse Width Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03345576 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants accepted into this research endeavor?

"Affirmative. The information available on clinicaltrials.gov attests that this medical experiment, first published on July 1st 2018, is presently recruiting participants. 24 individuals need to be enrolled from a single research centre."

Answered by AI

Does the FDA recognize Testosterone and LPWS as safe treatments?

"Taking into consideration the stage of development for Testosterone and LPWS, our team at Power rated their safety as a 2. This is indicative that while there are certain datapoints surrounding safety, efficacy has yet to be demonstrated."

Answered by AI

Who is deemed an ideal candidate for this trial?

"This trial seeks individuals who have experienced spinal cord injuries and are of legal age, between 18-70 years old. The study is looking to enrol 24 patients in total."

Answered by AI

Are there any vacancies for participants in this trial?

"As evidenced on clinicaltrials.gov, the study is actively recruiting participants since it was first posted on July 1st 2018 and recently updated April 5th 2022."

Answered by AI

Could you please provide details about prior investigations related to Testosterone and LPWS?

"Currently, 29 trials examining the efficacy of Testosterone and LPWS are running. Of these experiments, 5 have graduated to Phase 3 testing. Although many of the studies connected to this treatment are based in Houston, Texas, there is a total of 124 research centres conducting such tests around the nation."

Answered by AI

What are the typical indications for Testosterone and LPWS treatment?

"Testosterone and LPWS have demonstrated efficacy in treating hypogonadotropic hypogonadism, as well as post-menopausal conditions that occur within the span of 1 to 5 years. These treatments are also commonly prescribed for orchidectomy and orchitis patients."

Answered by AI

Does this research endeavor open to younger participants under 25 years old?

"This study specifies that applicants aged 18 to 70 are eligible. Additionally, there exist 37 trials for individuals under the age of majority and 326 studies dedicated to those over pensionable age."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Feb 2025