Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04604951
Eligibility Criteria:
A participant must meet all of the following criteria in order to be eligible for inclusion:
1. Resident of British Columbia, Canada with active provincial medical services plan
2. Male or female, 18-65 years of age
3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
4. \>1-year post injury, at least 6 months from any spinal surgery.
5. Documented presence of bladder dysfunction (NDO during UDS)
6. Documented presence of bowel or sexual dysfunction.
7. American Spinal Injury Association Impairment Scale (AIS) A, B.
8. Greater than or equal to antigravity strength in deltoids and biceps bilaterally
9. Hand function sufficient to perform Clean Intermittent Catheterization (CIC) or a committed caregiver to provide CIC for management of urinary bladder drainage.
10. Participants must have documented three days of bladder and bowel history prior to their baseline visit.
11. Willing and able to comply with all clinic visits and study-related procedures. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
12. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities.
13. Stable management of spinal cord related clinical issues (i.e., spasticity management).
14. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
15. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
Women of childbearing potential must agree to use adequate contraception\*\~2\~\* during the period of the trial and for at least 28 days after completion of treatment.
16. Effective contraception includes abstinence. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
17. Must provide informed consent.
Exclusion Criteria:
A participant who meets any of the following criteria will be ineligible to participate:
1. Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications \[tricyclics\]; or unstable diabetes. The following conditions apply:
1. Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
2. Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin \[total\]; GGT) as judged by the investigator.
2. Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
3. Ventilator dependent
4. Clinically significant depression or ongoing drug abuse
5. 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.
6. Intrathecal baclofen pump.
7. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
8. Any implanted metal in trunk or spinal cord under the sites of application of electrodes (between anode and cathode) for those who are allocated to receive TCSCS.
9. Severe anemia (Hgb\<8 g/dl) or hypovolemia
10. Participant is a member of the investigational team or his /her immediate family.
11. Participant has undergone electrode implantation surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04604951
Study Brief:
Protocol Section:
NCT04604951