RECRUITING

Spinal Decompression Plus Nerve Graft Implantation Following TSCI

Conditions

Spinal Cord Injuries Acute Traumatic Spinal Cord Injury Decompression Dorsal Duraplasty Myelotomy Nerve Graft

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Evaluation 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

Quick Facts

Study Start:2024-04-19

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06243211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age: = 18 years and = 80 years 2. Written informed consent by patient or legal authorized representative 3. No other life-threatening injury 4. No evidence of sepsis 5. Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission 6. Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12 7. The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury	1. Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours 2. Acute SCI with ASIA Impairment Scale grade C, D or E 3. Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required) 4. Currently involved in another non-observational SCI research study or receiving another investigational drug 5. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator) 6. Unable to commit to the follow-up schedule 7. 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 8. Any condition likely to result in the patient's death within the next 12 months 9. Prisoner 10. Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented). 11. Pregnancy

Inclusion Criteria

Exclusion Criteria

1. Age: = 18 years and = 80 years
2. Written informed consent by patient or legal authorized representative
3. No other life-threatening injury
4. No evidence of sepsis
5. Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission
6. Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
7. The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury

1. Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours
2. Acute SCI with ASIA Impairment Scale grade C, D or E
3. Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required)
4. Currently involved in another non-observational SCI research study or receiving another investigational drug
5. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator)
6. Unable to commit to the follow-up schedule
7. 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
8. Any condition likely to result in the patient's death within the next 12 months
9. Prisoner
10. Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).
11. Pregnancy

Contacts and Locations

Study Contact

Francis H Farhadi, MD, PhD

CONTACT

859-323-5661

francis.farhadi@uky.edu

Kris P Dyer, MPH, BS

CONTACT

859-323-4533

kris.dyer@uky.edu

Principal Investigator

Francis H Farhadi, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky Neurosurgery

Study Locations (Sites)

University of Kentucky - Chandler Medical Center

Lexington, Kentucky, 40536

United States

Collaborators and Investigators

Sponsor: H. Francis Farhadi

Francis H Farhadi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky Neurosurgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-19

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-04-19

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Decompression
Dorsal
Duraplasty
Myelotomy
Nerve Graft

Additional Relevant MeSH Terms

Spinal Cord Injuries
Acute Traumatic Spinal Cord Injury