euroinflammation and PET-CT imaging as a diagnostic tool following spinal cord injury

Phase 1

Recruiting

• Conditions: Spinal Cord Injury; Injuries and Accidents - Other injuries and accidents; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001946202
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-30
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Male, or female
2.Aged between 18 and 75 years (inclusive)
6.Medically stable, in the opinion of the treating physician
3.4.Have sustained a complete or incomplete, traumatic spinal cord injury, or, have a non-traumatic spinal cord injury (e.g. a spinal cord injury caused by multiple sclerosis, amyotrophic lateral sclerosis, cancer metastasis to spine)
4.Have complete or incomplete SCI, taking complete as the absence of sensory and motor functions in the lowest sacral segments, as per the International Standard for the Neurological Classification of SCI (ISNCSCI) 2011 revision
5.Have International Standard for the Neurological Classification of SCI (ISNCSCI) Grade A, Grade B, Grade C or Grade D at acute admission
6.Have neurological level between C4 and L1, taking this as the most caudal segment with normal motor and sensory functions on both sides of the body (ISNCSCI; revised 2011)
7.Have submitted to either spinal instrumentation (carbon fibre, or metal fixation in situ), or conservative stabilisation
8.Are agreeable to sequence analysis for the r.s. 6971 phenotype

Exclusion Criteria

1.Pregnant or breastfeeding
2.Have history of stroke, or TBI, brachial plexus lesion, or any other serious medical condition; e.g. malignancies, psychiatric, or illicit drug-dependence, which is likely to influence the patient’s ability to participate
3.Have active osteomyelitis, Paget’s disease, or severe kypho/scoliosis
4.Have spasticity, or autonomic dysreflexia (AD) unresponsive to standard care, as advised by the treating physician
5.Have pressure ulcer(s) on the pelves or proximal femur, or other contraindications to participating in the PET-CT imaging protocol, or outcome assessments, as advised by the treating physician
6.Have medical history of alcohol dependence or medical/ cultural contraindication to alcohol exposure
7.Have active, or previous participation in investigational drug study within 30 days of enrolment
8.Considered unwilling, unable or unlikely to comply with the study protocol
9.Have English language competency insufficient to understand research procedures, or are unable to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified