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临床试验/NCT06243211
NCT06243211招募中不适用

Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty

Francis Farhadi2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
2
主要终点
SCIM- Spinal Cord Independence Measures vIII

研究概览

简要总结

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).

详细描述

Spinal cord injury (SCI) is associated with devastating personal burdens including paralysis, sensory changes, autonomic dysfunction, and chronic debilitating pain. Few effective treatments have been developed with standard of care consisting of state-of-the-art neurocritical care, timely surgical decompression, and rehabilitation. While a variety of novel neuroprotective and neuroregenerative approaches have been posited, clinical trials to date have failed to demonstrate associated clinical benefits.

Current therapies are primarily aimed at reducing secondary injury processes, which are related to inflammation and ischemia, that persist over days-to-weeks following the primary mechanical insult. Intraparenchymal progressive hemorrhagic necrosis and swelling within the restrictive physical barrier of the pial and dural layers leads to further compression and ischemia, propagating the secondary injury cascade.

Early surgical bony decompression following SCI is thought to improve clinical outcomes, specifically after cervical-level injuries.

While few developments have been made in actual surgical techniques beyond bony decompression, early reports suggest that reduction of intraspinal pressure (ISP) could reduce secondary injury. Long-recognized but not clinically employed techniques to reduce ISP involve fashioning a dorsal midline myelotomy to allow for intramedullary decompression of hematoma and necrotic tissue and expansion of the dural compartment by opening the dura and sewing in of an expansive patch.

Corollary techniques have long been standard-of-care following cranial trauma: removal of the calvarial bone, evacuation of hematoma, expansive dural closure, and treatment of intra-cranial pressure have been proven effective in several randomized clinical trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Single-blinded (with outcome assessors blinded to treatment allocation)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).
  • Pregnancy

结局指标

主要结局

SCIM- Spinal Cord Independence Measures vIII

时间窗: Day 84 through day 364

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).

AIS (2019)

时间窗: Screening through day 364

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

次要结局

未报告次要终点

研究者

发起方
Francis Farhadi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francis Farhadi

Associate Professor, Neurosurgery

University of Kentucky

研究点 (2)

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