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Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

NCT04058821 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-08-16

No results posted yet for this study

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.

Conditions

  • Brain Injuries

Interventions

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)

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058821 on ClinicalTrials.gov