Trial Outcomes & Findings for Testosterone and Long Pulse Stimulation After SCI (NCT NCT03345576)
NCT ID: NCT03345576
Last Updated: 2025-10-14
Results Overview
Magnetic resonance imaging (MRI): The skeletal muscle area will be measured at baseline 6 months and 12 months after training (post-intervention).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline, 6 months and 12 months
Results posted on
2025-10-14
Participant Flow
Each participant underwent a detailed history and physical exam by a certified study medical provider to ensure eligibility. This was followed by electrodiagnosis to ensure denervation of the knee extensor muscle groups.
Participant milestones
| Measure |
Testosterone and LPWS
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
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.
Testosterone and standard NMES: 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.
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|---|---|---|
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Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Testosterone and LPWS
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
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.
Testosterone and standard NMES: 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.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
Baseline characteristics by cohort
| Measure |
Testosterone and LPWS
n=6 Participants
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
n=6 Participants
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.
Testosterone and standard NMES: 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.
|
Total
n=12 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
0 Participants
n=107 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
0 Participants
n=206 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
6 Participants
n=107 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
12 Participants
n=206 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
0 Participants
n=107 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
0 Participants
n=206 Participants • Two participants withdrew after signing consent and being randomized without performing any intervention or study procedures.
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 12 • n=99 Participants • Two participants withdrew prior to performing any study procedures.
|
47 years
STANDARD_DEVIATION 8 • n=107 Participants • Two participants withdrew prior to performing any study procedures.
|
45 years
STANDARD_DEVIATION 10 • n=206 Participants • Two participants withdrew prior to performing any study procedures.
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants • Two participants withdrew after signing consent forms without conducting any study procedures.
|
0 Participants
n=107 Participants • Two participants withdrew after signing consent forms without conducting any study procedures.
|
0 Participants
n=206 Participants • Two participants withdrew after signing consent forms without conducting any study procedures.
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants • Two participants withdrew after signing consent forms without conducting any study procedures.
|
6 Participants
n=107 Participants • Two participants withdrew after signing consent forms without conducting any study procedures.
|
12 Participants
n=206 Participants • Two participants withdrew after signing consent forms without conducting any study procedures.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: We are reporting the results of magnetic resonance imaging analysis of the right whole thigh muscle cross-sectional area (CSA, cm\^2) and knee extensor CSA (CSA, cm\^2) at baseline, 6 months and 12 months of completion of Testosterone and LPWS or Testosterone and standard NMES.
Magnetic resonance imaging (MRI): The skeletal muscle area will be measured at baseline 6 months and 12 months after training (post-intervention).
Outcome measures
| Measure |
Testosterone and LPWS
n=6 Participants
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
n=6 Participants
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.
Testosterone and standard NMES: 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.
|
|---|---|---|
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Muscle Size Change
Thigh Muscle CSA-BL (cm^2)
|
47.76 Muscle CSA (cm^2)
Standard Deviation 12.76
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31.1 Muscle CSA (cm^2)
Standard Deviation 12.65
|
|
Muscle Size Change
Whole Thigh Muscle CSA (cm^2) 6 months
|
52.4 Muscle CSA (cm^2)
Standard Deviation 16.7
|
36.0 Muscle CSA (cm^2)
Standard Deviation 9.96
|
|
Muscle Size Change
Whole Thigh Muscle CSA (cm^2) 12 months
|
42.87 Muscle CSA (cm^2)
Standard Deviation 22.4
|
41.1 Muscle CSA (cm^2)
Standard Deviation 12.6
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SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: The numbers in P2 or at 12 months were different because of earlier withdrawal of participants from the study.
Using indirect canopy after overnight 10-12 hours fast.
Outcome measures
| Measure |
Testosterone and LPWS
n=5 Participants
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
n=5 Participants
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.
Testosterone and standard NMES: 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.
|
|---|---|---|
|
Basal Metabolic Rate
BMR-BL
|
1634 Basal Metabolic Rate (BMR; Kcal/day)
Standard Deviation 416
|
1580 Basal Metabolic Rate (BMR; Kcal/day)
Standard Deviation 383
|
|
Basal Metabolic Rate
BMR- 6 Months
|
1564 Basal Metabolic Rate (BMR; Kcal/day)
Standard Deviation 428
|
1424 Basal Metabolic Rate (BMR; Kcal/day)
Standard Deviation 250
|
|
Basal Metabolic Rate
BMR- 12 Months
|
1385 Basal Metabolic Rate (BMR; Kcal/day)
Standard Deviation 182
|
1671 Basal Metabolic Rate (BMR; Kcal/day)
Standard Deviation 194
|
SECONDARY outcome
Timeframe: Mitochondrial measurements were conducted over 1 year period at baseline [BL, before starting any intervention], Post-intervention 1 [ P1; 6 months after starting interventions] and Post-intervention 2 [P2-12 months after starting interventions]Population: Three participants withdrew from Testosterone and LPWS before P2 as well as two participants withdrew from testosterone and standard NMES group before conducting P2.
Performing a simple muscle biopsy and them muscle samples will be assayed to measure mitochondrial citrate synthase and other complexes.
Outcome measures
| Measure |
Testosterone and LPWS
n=5 Participants
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
n=5 Participants
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.
Testosterone and standard NMES: 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.
|
|---|---|---|
|
Mitochondrial Complex Activities
Complex II-Baseline
|
43 nmol/min/mg
Standard Deviation 63
|
46 nmol/min/mg
Standard Deviation 45
|
|
Mitochondrial Complex Activities
Complex II-Post-intervention 1
|
47 nmol/min/mg
Standard Deviation 39
|
36 nmol/min/mg
Standard Deviation 31
|
|
Mitochondrial Complex Activities
Complex II-Post-intervention 2
|
14 nmol/min/mg
Standard Deviation 0.9
|
13 nmol/min/mg
Standard Deviation 10
|
Adverse Events
Testosterone and LPWS
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Testosterone and Standard NMES
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone and LPWS
n=6 participants at risk
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
n=6 participants at risk
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.
Testosterone and standard NMES: 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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
33.3%
2/6 • Number of events 2 • through study completion during the entire course of the intervention until the end of the study or until withdrawal from the trial up to 12 months.
|
0.00%
0/6 • through study completion during the entire course of the intervention until the end of the study or until withdrawal from the trial up to 12 months.
|
Other adverse events
| Measure |
Testosterone and LPWS
n=6 participants at risk
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.
Testosterone and LPWS: 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.
|
Testosterone and Standard NMES
n=6 participants at risk
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.
Testosterone and standard NMES: 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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritations as result of using testosterone patches
|
16.7%
1/6 • Number of events 1 • through study completion during the entire course of the intervention until the end of the study or until withdrawal from the trial up to 12 months.
|
0.00%
0/6 • through study completion during the entire course of the intervention until the end of the study or until withdrawal from the trial up to 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place