Clinical Trial

Duraplasty for Acute Traumatic Spinal Cord Injury

Study acronym: DATSCI
Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if a procedure called "expansile duraplasty" can improve recovery in adults who have experienced an acute traumatic spinal cord injury (SCI). The main questions it aims to answer are: * Does expansile duraplasty work to improve recovery in people with acute traumatic SCI? * How safe is the use of expansile duraplasty in people with acute traumatic SCI? Researchers will compare the strength, movement, and overall recovery of participants who receive expansile duraplasty to that of participants who do not receive expansile duraplasty to see if the use of expansile duraplasty leads to better recovery for people with acute traumatic SCI. Participants will be randomly placed in one of two groups: an Experimental group and a Control group. Participants in the Experimental group will receive expansile duraplasty during their standard SCI surgery. Participants in the Control group will not receive expansile duraplasty during their standard SCI surgery. All participants will: * Provide samples of blood and cerebrospinal fluid * Undergo magnetic resonance imaging (MRI) scans * Undergo an assessment of the ability to move arms/legs and feel touch or pin prick * Answer questionnaires about medical history, pain, health, and independence with activities of daily living
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-05-08
Trial Details
NCT Number NCT07280351
Lead Sponsor University of California, San Francisco
Collaborators: United States Department of Defense, Congressionally Directed Medical Research Programs
Conditions Spinal Cord Injury, Acute, Spinal Cord Injury (SCI), Initial Encounter, Spinal Cord Injury Cervical
Enrollment 66 participants
Start Date 2026-05-04
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-21