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Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058821
Enrollment
78
Registered
2019-08-16
Start date
2019-01-29
Completion date
2019-09-30
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

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 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.

Interventions

DIAGNOSTIC_TESTNovel 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_TESTNovel 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_TESTFunctional 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_TESTFunctional 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)

Sponsors

The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus7 minsdiagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus

Countries

United Kingdom

Contacts

Primary ContactRyckie Wade
ryckiewade@nhs.net0113 392 3355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026