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DMED for Spinal Cord Injury

N/A

Recruiting

Led By Francis H Farhadi, MD, PhD

Research Sponsored by University of Kentucky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No other life-threatening injury

No evidence of sepsis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84 through day 364

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a surgical procedure on the spinal cord after a traumatic injury. Ten participants will be split into two groups, with one group receiving the surgery alone and the other

Who is the study for?

This trial is for adults aged 18-80 with acute traumatic spinal cord injury (SCI) at certain levels of the spine, who can consent and have surgery within 48 hours post-injury. Excluded are those with mild SCI, other serious conditions or mental impairments, substance abuse issues, pregnancy, involvement in another SCI study or if anterior-only spinal surgery is suitable.Check my eligibility

What is being tested?

The study tests two surgical methods for treating acute SCI: DMED alone versus DMED combined with ANGI. It's a small-scale test to see if adding nerve grafts helps recovery. Participants won't know which treatment they get and neither will the assessors evaluating them.See study design

What are the potential side effects?

Potential side effects may include typical surgical risks like infection or reaction to anesthesia, as well as specific complications from nerve grafting such as donor site pain or sensory changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any other life-threatening conditions.

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I do not have sepsis.

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My spinal cord injury is between my neck and mid-back without piercing the cord.

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I can have surgery through the back within 2 days of my injury.

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I am between 18 and 80 years old.

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My spinal cord injury is severe, with complete or almost complete loss of movement below the injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84 through day 364

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84 through day 364

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 through day 364 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AIS (2019)

SCIM- Spinal Cord Independence Measures vIII

Trial Design

2Treatment groups

Active Control

Group I: DMEDActive Control1 Intervention

Dorsal myelotomy and expansive duraplasty (DMED) only.

Group II: DMED + ANGIActive Control2 Interventions

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor

187 Previous Clinical Trials

226,954 Total Patients Enrolled

Spinal Cord and Brain Injury Research Center (SCOBIRC)UNKNOWN

H. Francis FarhadiLead Sponsor

2 Previous Clinical Trials

375 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently available to prospective participants?

"Indeed, the details on clinicaltrials.gov indicate that this trial is currently enrolling participants. The study was initially listed on January 31st, 2024, and last modified on January 28th of the same year. Recruitment aims to secure participation from 10 individuals at a single designated site."

Answered by AI

Am I eligible to be a part of this medical study?

"Candidates must have sustained a spinal cord injury and be between 18 to 80 years old. The study will enroll approximately 10 participants."

Answered by AI

What is the current number of participants being recruited for this clinical investigation?

"Yes, the details on clinicaltrials.gov highlight that this investigation is presently in need of volunteers. The trial was initially uploaded on January 31st, 2024 and last revised on January 28th, 2024. It aims to enroll 10 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Decompression Plus Nerve Graft Implantation Following TSCI

H. Francis Farhadi 2024. "Spinal Decompression Plus Nerve Graft Implantation Following TSCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06243211.

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