Evidence map›Paper›PMID 40624376›Full record

ArticleNeurosurgical review2025

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.

Zahraa Al-Sharshahi, Jared T Wilcox, Hassan Darabi, Harshit Arora, Jorge E Quintero, Greg A Gerhardt, Craig G van Horne, Francis Farhadi

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Publisher
In one paragraph

Article in Neurosurgical review, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06243211 (Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06243211 narecruitingnot on this map

Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty

TypeinterventionalSponsorFrancis FarhadiRan2024 to 2026Enrolled10ConditionsSpinal Cord Injuries, Acute Traumatic Spinal Cord InjuryArmsDMED, ANGI
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Zahraa Al-SharshahiDepartment of Neurosurgery, University of Kentucky College of Medicine, 780 Rose Street, Medical Science Bldg., Room MS103B, 40536-0298, Lexington, USA.
Jared T WilcoxDepartment of Neurosurgery, University of Kentucky College of Medicine, 780 Rose Street, Medical Science Bldg., Room MS103B, 40536-0298, Lexington, USA.
Hassan DarabiDepartment of Neurosurgery, University of Kentucky College of Medicine, 780 Rose Street, Medical Science Bldg., Room MS103B, 40536-0298, Lexington, USA.
Harshit AroraDepartment of Neurosurgery, University of Kentucky College of Medicine, 780 Rose Street, Medical Science Bldg., Room MS103B, 40536-0298, Lexington, USA.
Jorge E QuinteroNeurorestoration Center, Department of Neuroscience, Department of Neurosurgery, University of Kentucky College of Medicine, Lexington, KY, USA.
Greg A GerhardtNeurorestoration Center, Department of Pharmaceutical Science, Department of Neuroscience, Department of Neurosurgery, University of Kentucky College of Medicine, Lexington, KY, USA.
Craig G van HorneNeurorestoration Center, Department of Neuroscience, Department of Neurosurgery, University of Kentucky College of Medicine, Lexington, KY, USA.
Francis FarhadiDepartment of Neurosurgery, University of Kentucky College of Medicine, 780 Rose Street, Medical Science Bldg., Room MS103B, 40536-0298, Lexington, USA. Francis.Farhadi@uky.edu.

Funding

Phase I Cell Therapy for Maintaining Cholinergic Circuits in the Spectrum of Alzheimer’s DiseaseR01AG081356 · NIA · UNIVERSITY OF KENTUCKY · PI Greg A. Gerhardt, Jorge E Quintero · 2024 to 2026
$2.0M
NIA NIH HHS R01 AG081356
6 · The paper itself

Abstract

backgroundTraumatic spinal cord injury (tSCI) is a devastating condition marked by persistent neurologic deficits. Secondary injury processes following tSCI, including progressive hemorrhagic necrosis and elevated intraspinal pressure (ISP), contribute to ongoing neurologic deterioration. Existing therapeutic strategies have shown limited efficacy, emphasizing the critical need for innovative interventions. This phase 1 study introduces a novel approach involving dorsal myelotomy and expansive duroplasty (DMED) with or without autologous nerve graft implantation (ANGI) for acute tSCI. The study aims to specifically assess the safety, feasibility, and preliminary efficacy of DMED and ANGI ("Decompression-Plus"). Inspired by cranial trauma management, expansive duroplasty represents a promising approach given that the dura can propagate ischemic injury. ANGI provides a unique opportunity for cell-based therapy without the logistical challenges associated with cell culture, allografts, or immunosuppression.

methodsA total of 10 participants presenting to the emergency department and diagnosed with acute ASIA impairment scale A/B cervico-thoracic tSCI will be consented and blinded prior to undergoing either DMED alone or Decompression-Plus (1:1 ratio). Rigorous monitoring of adverse events with institutional data safety monitoring board oversight will be performed through regular clinical, laboratory, and imaging evaluations. Feasibility will be assessed by monitoring of recruitment rates, procedural adherence, and participant compliance. Clinical outcomes will be measured by American Spinal Injury Association impairment scale assessments.

conclusionDMED with or without ANGI represent novel interventions for managing acute tSCI. The results of this phase 1 trial will determine whether these interventions can be performed safely and feasibly in a consecutive cohort of patients to potentially enhance recovery and improve outcomes. TRIAL REGISTRATION NUMBERS: Clinicaltrials.gov - NCT06243211 ( https://clinicaltrials.gov/study/NCT06243211?term=NCT06243211&rank=1 ) and UK Institutional Review Board - 91630.

Indexed as

Decompression, SurgicalDura MaterSpinal Cord InjuriesAdultClinical Trials, Phase I as TopicFemaleHumansMaleMiddle AgedPilot ProjectsRandomized Controlled Trials as TopicTransplantation, AutologousTreatment OutcomeCell-based therapyDuroplastyIntraspinal pressureMyelotomyPeripheral nerve graftSpinal cord injury

Identifiers

PMID40624376

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.