Spinal Decompression Plus Nerve Graft Implantation Following TSCI
Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty
Francis Farhadi
10 participants
Apr 19, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria7
- 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 Criteria11
- 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 documented).
- Pregnancy
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Interventions
Decompression of spinal cord with stabilization - posterior approach.
Implantation of nerve tissue following decompression ans stabilization.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06243211