ISRCTN17856698进行中（未招募）Unknown
Impact of transcutaneous spinal cord stimulation on autonomic cardiovascular control and upper-body exercise performance in individuals with a spinal cord injury (STIMEX-SCI): An exploratory study
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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 presence of persistent low resting BP and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension. This will be assessed using the 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.
排除标准
- •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 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 not 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.
研究者
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