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

NCT ID: NCT03253952

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-29

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma, Spinal Cord SPINAL Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traumatic Spinal Cord Injury

Observational study - monitoring immune response and heart rate variability

No interventions assigned to this group

Traumatic Spine Fracture, Control Group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Jan Schwab

Director of Spinal Cord Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan M Schwab, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2016H0369

Identifier Type: -

Identifier Source: org_study_id

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