Spinal Decompression Plus Nerve Graft Implantation Following TSCI

NCT06243211 | Recruiting

• 1 other identifier: 91630
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Traumatic Spinal Cord Injury; Spinal Cord Injuries

Keywords

Decompression; Dorsal; Duraplasty; Myelotomy; Nerve Graft

Outcome Measures

Primary Outcomes (2)

• SCIM- Spinal Cord Independence Measures vIII

  The SCIM has been developed to address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors).

  Day 84 through day 364

• AIS (2019)

  American Spinal Injury Association International standards for neurological classification of spinal cord injury Assessment

  Screening through day 364

Study Arms (2)

DMED

ACTIVE COMPARATOR

Dorsal myelotomy and expansive duraplasty (DMED) only.

Procedure: DMED

DMED + ANGI

ACTIVE COMPARATOR

Dorsal myelotomy and expansive duraplasty (DMED) and supplemental autologous nerve graft implantation (ANGI).

Procedure: DMED; Procedure: ANGI

Interventions

DMED PROCEDURE

Decompression of spinal cord with stabilization - posterior approach.

Also known as: Spinal Cord decompression and stabilization

DMED; DMED + ANGI

ANGI PROCEDURE

Implantation of nerve tissue following decompression ans stabilization.

Also known as: Autologous Nerve Graft Implantation

DMED + ANGI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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 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
• Pregnancy

Sponsors & Collaborators

• Francis Farhadi: lead
• Spinal Cord and Brain Injury Research Center (SCOBIRC): collaborator

Study Sites (1)

University of Kentucky - Chandler Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

Related Publications (1)

• Al-Sharshahi Z, Wilcox JT, Darabi H, Arora H, Quintero JE, Gerhardt GA, van Horne CG, Farhadi F. Design and protocol for the decompression-plus trial: a phase 1 clinical study of dorsal myelotomy and expansive duroplasty with or without autologous nerve grafting in acute traumatic spinal cord injury. Neurosurg Rev. 2025 Jul 8;48(1):547. doi: 10.1007/s10143-025-03701-z.

  PMID: 40624376 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Francis H Farhadi, MD, PhD

  University of Kentucky Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis H Farhadi, MD, PhD

CONTACT

859-323-5661; francis.farhadi@uky.edu

Harshit Arora, PhD

CONTACT

859-323-4533; harshit.arora@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blinded (with outcome assessors blinded to treatment allocation)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Model Details: 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).

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)