Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

Brain Injuries Clinical Trial

Official title:

Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058821
• Other study ID #: PL18/110632
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Ryckie Wade
• Phone: 0113 392 3355
• Email: ryckiewade[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Diagnostic Test:
• Novel MRI scan - 7 days post injury
A turbo spin-echo localiser (20 seconds) Single-shot echo planar diffusion tensor imaging (7 minutes) 3D constructive interference in steady state (CISS, 6 minutes) Phase-sensitive inversion-recovery gradient echo with cardiac gating (4 minutes)
• Novel MRI scan - 14 days post injury
A turbo spin-echo localiser (20 seconds) Single-shot echo planar diffusion tensor imaging (7 minutes) 3D constructive interference in steady state (CISS, 6 minutes) Phase-sensitive inversion-recovery gradient echo with cardiac gating (4 minutes)
• Functional MRI scan - 6 months post brachial plexus exploration
Continuous whole brain echo-planar imaging High-resolution T1-weighted imaging of the brain Bilateral magnetic resonance spectroscopy (12 minutes)
• Functional MRI scan - 12 months post brachial plexus exploration
Continuous whole brain echo-planar imaging High-resolution T1-weighted imaging of the brain Bilateral magnetic resonance spectroscopy (12 minutes)

Locations

Country	Name	City	State
United Kingdom	St James's University Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus	diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus	7 mins