Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

The Leeds Teaching Hospitals NHS Trust

Status: Unknown

Conditions: Brain Injuries

Treatments: Diagnostic Test: Novel MRI scan - 14 days post injury; Diagnostic Test: Functional MRI scan - 6 months post brachial plexus exploration; Diagnostic Test: Functional MRI scan - 12 months post brachial plexus exploration; Diagnostic Test: Novel MRI scan - 7 days post injury

Study type: Interventional

Funder types: Other

Identifiers

NCT04058821

PL18/110632

Details and patient eligibility

About

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 MRI.

The nerves which control movement and feeling in the arm can be severely damaged in eg. motorbike crashes, sporting or work-related injuries. Every year 500 adults sustain life-changing major nerve injuries, causing 1) disability needing constant care, 2) life-long pain and 3) mental illness. In England, major nerve injuries cost £250million every year in hospital treatments, unemployment and social care. Injured nerves can be repaired with surgery.

To decide if nerves need repairing, exploratory surgery is needed. Instead, we have developed a new MRI scan which could diagnose nerve injuries, meaning that exploratory surgery could be avoided, nerve injuries could be diagnosed sooner and reconstructive surgery performed sooner.

Some people with nerve injuries develop lifelong pain - if we could understand how the brain adapts, we could learn how to prevent nerve pain. Also, some people don't recover movement in their hand - if we could understand how the brain reorganises nerves controlling movement, we could predict who would benefit from surgery.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Adults with traumatic brachial plexus injuries

Experimental group

Description:

Participants will have two MRI scans before surgery (to find out the best time to scan), then two after surgery (at 6 and 12 months).

Treatment:

Diagnostic Test: Novel MRI scan - 14 days post injury

Diagnostic Test: Functional MRI scan - 6 months post brachial plexus exploration

Diagnostic Test: Novel MRI scan - 7 days post injury

Diagnostic Test: Functional MRI scan - 12 months post brachial plexus exploration