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New treatment option for Spinal Cord Injuries
Official title Spinal Decompression Plus Nerve Graft Implantation Following TSCI
ClinicalTrials.gov ID: NCT06243211
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Unable to commit to the follow-up schedule
See the full eligibility 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
- 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
- people who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.