This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs.
This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface - Commercial, ISI-C) that will be implanted.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.