Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries
• Intervention / Treatment: Diagnostic test: Novel MRI scan - 7 days post injury; 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

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryckie Wade; Phone Number: 0113 392 3355; Email: ryckiewade@nhs.net

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St James's University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adults with traumatic brachial plexus injuries; 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).

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); Diagnostic test: 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); Diagnostic test: 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); Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: PL18/110632

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No