Status:
UNKNOWN
Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Brain Injuries
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The aims are: 1. Investigate new magnetic resonance imaging (MRI) scans for diagnosing severe nerve injury in the arm. 2. Understand how the brain and spinal cord respond to severe nerve injury using...
Eligibility Criteria
Inclusion
- Adults with traumatic BPIs who require surgical exploration of the supraclavicular brachial plexus. A traumatic BPI is defined by the absence of any or all motor or sensory function in an upper limb, following trauma.
Exclusion
- Patients with an acutely ischaemic limb as they require immediate surgical intervention
- Unable to get into the MRI scanner due to habitus or claustrophobia
- Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)
- Intraocular or intracranial metallic foreign bodies
- Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve stimulators, etc) which are not MRI safe or conditional.
- Pregnancy - whilst there are no known adverse effects of MRI(129-131) to the mother or fetus, MRI is generally avoided in pregnancy due to the acoustic trauma(132) and inductive heating generated by alternating magnetic fields.
- Any pre-existing neurological disorder, injury or disease causing a functional impairment in the affected limb
- Patients lacking capacity to consent
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04058821
Start Date
January 29 2019
End Date
September 30 2019
Last Update
August 16 2019
Active Locations (1)
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1
St James's University Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF