Chronic (>1 year) motor-complete (AIS A-B) spinal cord injury between C4-T6 Nervous System Diseases
Conditions
Interventions
Current interventions as of 22/01/2026:
The project is formed of acute (Aim 1) and longitudinal (Aim 2) components. Aim 1 lasts 3 weeks with a total time commitment of approx. 11.5 hours, split acros
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/01/2026: For individuals with spinal cord injury: 1. Male or female of at least 16 years of age. 2. Chronic SCI (non-progressive, with motor-complete paralysis) between the C4 – T6 spinal segments and =1-year post injury. 3. Documented presence of cardiovascular dysfunction including the presence of persistent low resting BP and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension. This will be assessed using the Autonomic Dysfunction Following SCI questionnaire. 4. American Spinal Injury Association Impairment Scale A or B (motor-complete SCI). 5. Willing and able to comply with all clinic visits and study-related procedures. 6. Able to understand and complete study-related questionnaires (i.e., English language speaking only). 7. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities. 8. Can move their arms/hands voluntarily to operate the arm-crank ergometer. 9. Must provide informed consent. For non-injured individuals: 1. Male or female of at least 16 years of age. 2. Willing and able to comply with all clinic visits and study-related procedures. 3. Able to understand and complete study-related questionnaires (i.e., English language speaking only). 4. No painful musculoskeletal dysfunction, unhealed fracture, or active infection that may interfere with testing activities. 5. Must provide informed consent. Previous inclusion criteria: For individuals with spinal cord injury: 1. Male or female of at least 16 years of age. 2. Chronic SCI (non-progressive, with motor-complete paralysis) between the C5 – T6 spinal segments and =1-year post injury. 3. Documented presence of cardiovascular dysfunction including the presence of persistent low resting BP and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension. This will be assessed using the Autonomic Dysfunction Following SCI questionnaire. 4. American Spinal Injury Association Impairment Scale A or B (motor-complete SCI). 5. Willing and able to comply with all clinic visits and study-related procedures. 6. Able to understand and complete study-related questionnaires (i.e., English language speaking only). 7. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities. 8. Can move their arms/hands voluntarily to operate the arm-crank ergometer. 9. Must provide informed consent. For non-injured individuals: 1. Male or female of at least 16 years of age. 2. Willing and able to comply with all clinic visits and study-related procedures. 3. Able to understand and complete study-related questionnaires (i.e., English language speaking only). 4. No painful musculoskeletal dysfunction, unhealed fracture, or active infection that may interfere with testing activities. 5. Must provide informed consent.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/11/2024: For individuals with a spinal cord injury: 1. Presence of severe acute medical issues that in the investigator’s judgement would adversely affect the participant’s participation in the study. Examples include, but are not limited to, acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications (tricyclic antidepressants); or unstable diabetes. 2. Ventilator dependent 3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study. 4. Cardiovascular, cerebrovascular, respiratory, metabolic, musculoskeletal, bladder, or renal disease unrelated to SCI. 5. The individual is a member of the investigational team or his/her immediate family. 6. Any implanted metal in the trunk or spinal cord (between the anode and the cathode) that would prevent the use of TSCS. 7. Have previously suffered from brain trauma, a psychiatric disorder or epilepsy (including family history of epilepsy). 8. Are = currently taking neuromodulatory drugs. 9. Implanted with an epidural stimulator or other device that would contraindicate the use of electrical stimulation (e.g., stimulators, pacemakers, medication pumps etc.). 10. Females that are pregnant. 11. Does not speak English. For non-injured individuals: 1. Individuals with any acquired SCI (i.e. traumatic, infection, cancer). 2. Any known history of cardiovascular, cerebrovascular, respiratory, metabolic, musculoskeletal, bladder, or renal disease, or individuals with diabetes mellitus. A General Health Questionnaire will be administered to screen potential participants. 3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study. 4. Have previously suffered from brain trauma, a psychiatric disorder or epilepsy (including family history of epilepsy). 5. Females that are pregnant. 6. Does not speak English. _____ Previous exclusion criteria: For individuals with a spinal cord injury: 1. Presence of severe acute medical issues that in the investigator’s judgement would adversely affect the participant’s participation in the study. Examples include, but are not limited to, acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications (tricyclic antidepressants); or unstable diabetes. 2. Ventilator dependent 3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study. 4. Cardiovascular, cerebrovascular, respiratory, metabolic, musculoskeletal, bladder, or renal disease unrelated to SCI. 5. The individual is a member of the investigational team or his/her immediate family. 6. Any implanted metal in the trunk or spinal cord (between the anode and the cathode) that would prevent the use of TSCS. 7. Have not previously suffered from brain trauma, a psychiatric disorder or epilepsy (including family history of epilepsy). 8. Are not currently taking antidepressants or neuromodulatory drugs. 9. Implanted with an epidural stimulator. 10. Females that are pregnant. 11. Does not speak English. For non-injured individuals: 1. Individuals with any acquired SCI (i.e. traumatic, infection, cancer). 2. Any known history of cardiov
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/11/2024: Aim 1: Time to exhaustion assessed as the duration of exercise performed during an aerobic arm-crank exercise trial at a range of workloads corresponding to light, moderate and vigorous-intensity exercise, both with and without CV-TSCS. Aim 2: Cardiorespiratory fitness assessed as the peak oxygen uptake (V?O2peak) achieved during a graded cardiopulmonary exercise test performed on an arm-crank ergometer until volitional exhaustion. Expired gases will be collected using a calibrated, metabolic cart (Vyntus CPX, Jaeger, Germany). Cardiorespiratory fitness will be assessed pre-intervention, mid-intervention (Week 4) and post-intervention (Week 8). _____ Previous primary outcome measure: Aim 1: Time to fatigue assessed as the duration of exercise performed during an aerobic arm-crank exercise trial at a range of workloads corresponding to light, moderate and vigorous-intensity exercise, both with and without CV-TSCS. Aim 2: Cardiorespiratory fitness assessed as the peak oxygen uptake (V?O2peak) achieved during a graded cardiopulmonary exercise test performed on an arm-crank ergometer until volitional exhaustion. Expired gases will be collected using a calibrated, metabolic cart (Vyntus CPX, Jaeger, Germany). Cardiorespiratory fitness will be assessed pre-intervention, mid-intervention (Week 4) and post-intervention (Week 8). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/01/2026: Aim 1: 1. Blood pressure instability (self-report). Measured via the Autonomic Dysfunction Following SCI Questionnaire. Assessed at baseline. 2. Beat-to-beat heart rate, blood pressure and cerebrovascular blood velocity responses to a battery of autonomic nervous system stress tests. Measured via electrocardiogram, non-invasive finger plethysmography and Transcranial Doppler ultrasound, respectively. Assessed with and without CV-TSCS at baseline. 3. Respiratory function. Functional vital capacity, forced expiratory volume in 1 second, ratio (FEV1/FVC), and peak expiratory flow will be measured via standard spirometry testing procedures in accordance with the American Thoracic Society and European Respiratory Society. Assessed with and without CV-TSCS at baseline. 4. Gas exchange variables (oxygen uptake, respiratory exchange ratio, end tidal CO2). Measured via a calibrated, metabolic cart (Vyntus CPX, Jaeger, Germany). Assessed during the cardiopulmonary exercise test at baseline, familiarisation session and exercise trials with CV-TSCS and SHAM-TSCS. 5. Oxygen pulse. Measured using heart rate (Polar Electro, Kempele, Finland) and oxygen uptake (Vyntus CPX, Jaeger, Germany) and used as a reasonable surrogate for stroke volume. Assessed during the cardiopulmonary exercise test at baseline, familiarisation session and exercise trials with CV-TSCS and SHAM-TSCS. 6. Beat-to-beat cerebrovascular blood velocity in the left and right middle cerebral artery. Measured via Transcranial Doppler ultrasound. Assessed during the familiarisation session and exercise trials with CV-TSCS and SHAM-TSCS. 7. Haemodynamics and oxygenation of lower extremity skeletal muscle tissue. Measured using near-infrared spectroscopy (NIRS-500, Hamamatsu Photonics, Japan). Assessed during the familiarisation session and exercise trials with CV-TSCS and SHAM-TSCS. 8. Ratings of perceived exertion, exercise enjoyment and affective valence. Measure | — |
Countries
England, United Kingdom
Contacts
Public ContactDaniel Hodgkiss
Outcome results
None listed