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

Therapuetic Areas:Other
Age Range:18 - Any
Start Date:September 29, 2017
End Date:July 31, 2021
Contact:Aash Bhandari

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PROSPECT ADDITION SCI - A PROSPECTive 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.

Inclusion Criteria:

- Isolated traumatic SCI (ASIA A-D), surgical stabilization planned/performed, a
singular lesion (lesion can include more than one segment)

- Isolated spinal fracture without neurological abnormality (ASIA E) surgical
stabilization planned/performed

- Legal age of the patient (18)

- Ability to give informed consent

Exclusion Criteria:

- Non-traumatic SCI

- 2 or more spinal cord lesions definable from one another

- Polytrauma*

- Additional severe traumatic brain injury (TBI)*

- Neoplasia and/or antineoplastic therapy

- Rheumatic diseases / collagenosis / vasculitis

- Other autoimmune diseases

- Pre-existing acute/chronic infection

- Pre-existing systemic steroid treatment (except NASCIS)

- Severe alcohol or drug addiction
We found this trial at
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-366-3877
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Columbus, OH
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