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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT04302259
Eligibility Criteria:
Inclusion Criteria:
* • Adults (men or women) between the ages of 18 and 65 years old
* Complete or Incomplete SCI with AIS grade of A or B between the levels of C7/T1 and T10 (level and degree of injury based on the international standards for neurological classification of SCI (ISNCSCI))
* Focal area of SCI due to trauma
* SCI date of injury \> 1 year prior to enrollment
* Completed prior SCI rehabilitation program
* Ability to use both upper extremities to ambulate with a wheelchair or crutches
* Distance between the conus medullaris and site of injury must be \> 4 cm
* The ability to participate in intensive physical therapy and research \> 4 hours per day for 2 weeks
* Must provide informed consent prior to study participation
Exclusion Criteria:
* • Presence of co-existing lower extremity neuropathy or disorders of the cauda equina
* Presence of non-traumatic spinal cord pathology
* Significant cognitive impairment or decreased level of consciousness
* Presence of an intrathecal baclofen or morphine pump
* Presence of a cardiac defibrillator or pacemaker
* Presence of a deep brain stimulator device
* Patient who has any contraindication to having a MRI performed
* Severe or disabling joint contractures in the lower extremities
* Presence of hematologic disorder or medication related coagulopathy that would preclude surgery
* Lower extremity congenital or acquired deformities
* Women who are pregnant or who are unwilling to use contraception during the study period
* Body mass index \> 30
* Cardiopulmonary comorbidities that preclude participation in intensive physical therapy
* Known or suspected patient non-compliance during the study period and at follow up
* Patient life expectancy \< 12 months
* Presence of patient comorbidities or spinal anatomy that would preclude participation in the study per investigators' recommendation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04302259
Study Brief:
Protocol Section:
NCT04302259