Expansile Duraplasty for Spinal Cord Injury

(DATSCI Trial)

Overseen By TRACK-SCI Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Rajiv Saigal, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults who've recently suffered an acute traumatic spinal cord injury. To participate, they must be undergoing standard SCI surgery and willing to provide blood and cerebrospinal fluid samples, undergo MRI scans, have their movement assessed, and complete health questionnaires.

Inclusion Criteria

C3 - C7 neurological level of injury on ISNCSCI exam

Imaging showing cord compression

My spinal injury is classified between AIS A and C.

Exclusion Criteria

Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator

I have a spinal cord injury not caused by trauma, like an infection or tumor.

Injury arising from penetrating mechanism

What Are the Treatments Tested in This Trial?

Interventions

• Expansile duraplasty

Trial Overview The study tests if expansile duraplasty improves recovery in acute traumatic SCI patients. Participants are randomly assigned to either receive the procedure during standard surgery (Experimental group) or not (Control group), then monitored for strength, movement, and overall recovery.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Participants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.

Group II: Control Active Control 1 Intervention

Participants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Department of Defense Congressionally Directed Medical Research Program

Collaborator

Trials

3

Recruited

640+