💬In plain words
What the trial is, and whether it could suit you
This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, admitted to inpatient rehabilitation facilities (IRFs) or after discharged from IRFs. We will also examine the effect of tSCS on lower urinary tract (LUT) and bowel functions as secondary outcomes.
The main questions this study aims to answer are:
1. Assess the safety of single and repeated tSCS session(s) on cardiovascular function in the acute SCI: We will test the safety of single tSCS at T10-L2 session
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Are between 21-65 years of age.
2. SCI (non-progressive) at or above the T6 spinal segment.
3. Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
4. American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
5. Have stable medical condition that would permit participation in testing activities.
6. Willing and able to comply with all clinic visits and study-related procedures.
7. Able to understand and complete study-related questionnaires in English.
8. Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
9. Are not currently pregnant or not intending to become pregnant during participation in this study.
10. Are volunteering to be involved in this study.
11. Must provide informed consent.
Exclusion Criteria:
1. Have autoimmune etiology of spinal cord dysfunction/injury
2. Have history of additional neurologic disease, such as stroke, MS, etc.
3. Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
4. Are ventilator dependent.
5. Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
6. Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
7. Have Intrathecal baclofen pump.
8. Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
9. Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, pressure sores, or unstable diabetes.
10. Have pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators.
11. Are a member of the investigational team or his/her immediate family.
12. Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
13. Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
14. Have a history of seizures.
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