Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial
Introduction Long pulse width stimulation (LPWS; 120–150 ms) has the potential to stimulate denervated muscles and to restore muscle size in denervated people with spinal cord injury (SCI). We will determine if testosterone treatment (TT)+LPWS would increase skeletal muscle size, leg lean mass and i...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/10/e064748.full |
| _version_ | 1828140576615170048 |
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| author | Ashraf S Gorgey Refka E Khalil Ranjodh Gill Teodoro Castillo David X Cifu Edward J Lesnefsky Robert A Adler Malak Alrubaye Jeannie Rivers Lance L Goetz Deborah Caruso Timothy D Lavis Christopher C Cardozo |
| author_facet | Ashraf S Gorgey Refka E Khalil Ranjodh Gill Teodoro Castillo David X Cifu Edward J Lesnefsky Robert A Adler Malak Alrubaye Jeannie Rivers Lance L Goetz Deborah Caruso Timothy D Lavis Christopher C Cardozo |
| author_sort | Ashraf S Gorgey |
| collection | DOAJ |
| description | Introduction Long pulse width stimulation (LPWS; 120–150 ms) has the potential to stimulate denervated muscles and to restore muscle size in denervated people with spinal cord injury (SCI). We will determine if testosterone treatment (TT)+LPWS would increase skeletal muscle size, leg lean mass and improve overall metabolic health in persons with SCI with denervation. We hypothesise that the 1-year TT+LPWS will upregulate protein synthesis pathways, downregulate protein degradation pathways and increase overall mitochondrial health.Methods and analysis Twenty-four male participants (aged 18–70 years with chronic SCI) with denervation of both knee extensor muscles and tolerance to the LPWS paradigm will be randomised into either TT+neuromuscular electrical stimulation via telehealth or TT+LPWS. The training sessions will be twice weekly for 1 year. Measurements will be conducted 1 week prior training (baseline; week 0), 6 months following training (postintervention 1) and 1 week after the end of 1 year of training (postintervention 2). Measurements will include body composition assessment using anthropometry, dual X-ray absorptiometry and MRI to measure size of different muscle groups. Metabolic profile will include measuring of basal metabolic rate, followed by blood drawn to measure fasting biomarkers similar to hemoglobin A1c, lipid panels, C reactive protein, interleukin-6 and free fatty acids and then intravenous glucose tolerance test to test for insulin sensitivity and glucose effectiveness. Finally, muscle biopsy will be captured to measure protein expression and intracellular signalling; and mitochondrial electron transport chain function. The participants will fill out 3 days dietary record to monitor their energy intake on a weekly basis.Ethics and dissemination The study was approved by Institutional Review Board of the McGuire Research Institute (ID # 02189). Dissemination plans will include the Veteran Health Administration and its practitioners, the national SCI/D services office, the general healthcare community and the veteran population, as well as the entire SCI community via submitting quarterly letters or peer-review articles.Trial registration number NCT03345576. |
| first_indexed | 2024-04-11T19:11:54Z |
| format | Article |
| id | doaj.art-877316f48e42419abf50624a7a587852 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T19:11:54Z |
| publishDate | 2022-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-877316f48e42419abf50624a7a5878522022-12-22T04:07:35ZengBMJ Publishing GroupBMJ Open2044-60552022-10-01121010.1136/bmjopen-2022-064748Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trialAshraf S Gorgey0Refka E Khalil1Ranjodh Gill2Teodoro Castillo3David X Cifu4Edward J Lesnefsky5Robert A Adler6Malak Alrubaye7Jeannie Rivers8Lance L Goetz9Deborah Caruso10Timothy D Lavis11Christopher C Cardozo121Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA1Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA3Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA1Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA1Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA9Cardiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USAAmerican Society for Bone and Mineral Research co-chairSpinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USASpinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USASpinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USASpinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USASpinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USANational Center for the Medical Consequences of Spinal Cord Injury and Medical and Surgical Service, James J Peters VA Medical Center, Bronx, New York, USAIntroduction Long pulse width stimulation (LPWS; 120–150 ms) has the potential to stimulate denervated muscles and to restore muscle size in denervated people with spinal cord injury (SCI). We will determine if testosterone treatment (TT)+LPWS would increase skeletal muscle size, leg lean mass and improve overall metabolic health in persons with SCI with denervation. We hypothesise that the 1-year TT+LPWS will upregulate protein synthesis pathways, downregulate protein degradation pathways and increase overall mitochondrial health.Methods and analysis Twenty-four male participants (aged 18–70 years with chronic SCI) with denervation of both knee extensor muscles and tolerance to the LPWS paradigm will be randomised into either TT+neuromuscular electrical stimulation via telehealth or TT+LPWS. The training sessions will be twice weekly for 1 year. Measurements will be conducted 1 week prior training (baseline; week 0), 6 months following training (postintervention 1) and 1 week after the end of 1 year of training (postintervention 2). Measurements will include body composition assessment using anthropometry, dual X-ray absorptiometry and MRI to measure size of different muscle groups. Metabolic profile will include measuring of basal metabolic rate, followed by blood drawn to measure fasting biomarkers similar to hemoglobin A1c, lipid panels, C reactive protein, interleukin-6 and free fatty acids and then intravenous glucose tolerance test to test for insulin sensitivity and glucose effectiveness. Finally, muscle biopsy will be captured to measure protein expression and intracellular signalling; and mitochondrial electron transport chain function. The participants will fill out 3 days dietary record to monitor their energy intake on a weekly basis.Ethics and dissemination The study was approved by Institutional Review Board of the McGuire Research Institute (ID # 02189). Dissemination plans will include the Veteran Health Administration and its practitioners, the national SCI/D services office, the general healthcare community and the veteran population, as well as the entire SCI community via submitting quarterly letters or peer-review articles.Trial registration number NCT03345576.https://bmjopen.bmj.com/content/12/10/e064748.full |
| spellingShingle | Ashraf S Gorgey Refka E Khalil Ranjodh Gill Teodoro Castillo David X Cifu Edward J Lesnefsky Robert A Adler Malak Alrubaye Jeannie Rivers Lance L Goetz Deborah Caruso Timothy D Lavis Christopher C Cardozo Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial BMJ Open |
| title | Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial |
| title_full | Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial |
| title_fullStr | Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial |
| title_full_unstemmed | Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial |
| title_short | Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial |
| title_sort | testosterone and long pulse width stimulation tlps for denervated muscles after spinal cord injury a study protocol of randomised clinical trial |
| url | https://bmjopen.bmj.com/content/12/10/e064748.full |
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