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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT04726059
Eligibility Criteria:
INCLUSION CRITERIA
A participant must meet all of the following criteria in order to be eligible for inclusion:
* Resident of British Columbia, Canada with active provincial medical services plan
* Male or female, 18-60 years of age
* Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment
* At least 1-year post injury, at least 6 months from any spinal surgery
* American Spinal Injury Association Impairment Scale (AIS) A, B
* Able to tolerate an upright posture for 30 minutes (with or without breaks)
* 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)
* No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities
* Stable management of spinal cord related clinical issues (i.e., spasticity management)
* Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
1. 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
2. Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. 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
* Medication dosage must be stable for period of 4 weeks prior to participation
* Must provide informed consent
EXCLUSION CRITERIA
A participant who meets any of the following criteria will be ineligible to participate:
* Ventilator dependent
* Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse
* 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
* Intrathecal baclofen pump
* Oral baclofen dose or other anti-spasticity medications greater than 30mg per day
* Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones
* 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 acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes
* Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk
* History of osteoporosis, low bone mineral density, or fragility fractures in the lower limbs
* History of seizures/epilepsy or recurring headaches
* Participant has swollen, infected, and inflamed areas or open wounds on the area of stimulation
* Severe anemia (Hgb\<8 g/dl) or hypovolemia as measured by hematocrit via blood test in the last six months
* Participant is a member of the investigational team or his /her immediate family
* Participant has undergone electrode implantation surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04726059
Study Brief:
Protocol Section:
NCT04726059