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

NCT03253952 | Active Not Recruiting

• 1 other identifier: 2016H0369
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma, Spinal Cord; SPINAL Fracture

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

Traumatic Spinal Cord Injury

Observational study - monitoring immune response and heart rate variability

Traumatic Spine Fracture, Control Group

Observational study - monitoring immune response and heart rate variability acting as a control group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SCI patients (n=50 subjects), Isolated Spinal fracture patients (n=10)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan M Schwab, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Spinal Cord Medicine

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 18, 2017
• Study Start: September 29, 2017
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

US (1)