Spinal Decompression Plus Nerve Graft Implantation Following TSCI (NCT06243211) | Clinical Trial Compass
RecruitingNot Applicable
Spinal Decompression Plus Nerve Graft Implantation Following TSCI
United States10 participantsStarted 2024-04-19
Plain-language summary
This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury.
Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis).
Who can participate
Age range
18 Years – 80 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:
* Age: = 18 years and = 80 years
* Written informed consent by patient or legal authorized representative
* No other life-threatening injury
* No evidence of sepsis
* Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission
* Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
* The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury
Exclusion Criteria:
* Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours
* Acute SCI with ASIA Impairment Scale grade C, D or E
* Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required)
* Currently involved in another non-observational SCI research study or receiving another investigational drug
* Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator)
* Unable to commit to the follow-up schedule
* A recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study
* Any condition likely to result in the patient's death within the next 12 months
* Prisoner
* Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be docu…
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.