ClinicalTrials.gg
Active, not recruitingNCT03253952Updated Aug 11, 2025

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

An observational study in Trauma, Spinal Cord and SPINAL Fracture, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Spinal Cord Injuries by Ohio State University — 3 open to participants now, 4 under way, none of them phase 3. Spinal Cord Injuries · Ohio State University.

Started
2017
with 1 other
Observational
3 of 13
none open now
Registered
5th of 13
by date

Among the 13 studies in Spinal Cord Injuries by Ohio State University, this one is one of 2 that started in 2017, is one of 3 observational ones, and was the 5th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phase9 · 3 open
Observationalthis study3 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2013; this study’s year is marked. 2 started in 2017.

What they test

Size and results

Median enrollment 21 across the 10 interventional studies, 50 across the 3 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Spinal Cord Injuries by Ohio State University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Trauma, Spinal Cord
  • SPINAL Fracture
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 of the patient

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

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

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Jun 2025, 93 months.

Of 124 non-industry observational studies under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 74. This study's 93 months is above that.

Counting every sponsor, half of 135 studies reached it within 39 months; a quarter within 16 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2017
First posted
Aug 18, 2017
StartActual
Sep 29, 2017
Primary completionActual
Jun 30, 2025
CompletionEst.
Dec 31, 2027
Last update
Aug 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03253952
Responsible party
Jan Schwab (Director of Spinal Cord Medicine, Ohio State University) — Principal investigator
First posted
Aug 18, 2017
Start date
Sep 29, 2017
Primary completion
Jun 30, 2025
Completion
Dec 31, 2027 (estimated)
Last update
Aug 11, 2025

Study contacts

Jan M Schwab, MD, PhD
principal investigator · Ohio State University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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