A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.

The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in both the time and frequency domains to discriminate between the relative contribution of sympathetic and parasympathetic innervation to changes in HRV. The ability to predict infections will enable novel treatments thereby reducing infection-associated mortality and improving neurological and functional outcomes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Trauma, Spinal Cord Back Injuries Central Nervous System Diseases Fractures, Bone Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Fracture Spinal Fractures Spinal Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment
Patients with acute isolated spinal fracture, lesion may include more than 1 segment
Legal age of the patient
Documented informed consent of the patient

Exclusion criteria

Non-traumatic spinal cord injury
Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors)
Neoplasia and/or antineoplastic therapy
Pregnancy, lactation

Treatment and study plan

Primary outcomes

Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections

Time frame: At all study time-points for a period of 24hours.

Determining whether discrete signs of loss of autonomic control (dysautonomia), not meeting defined criteria of full-autonomic dysreflexia, also renders patients "at risk" for developing infections.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury

Important dates

Study start: 2017
Primary completion: 2025
Study completion: 2027
First posted: Aug 18, 2017
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting