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Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

Primary Purpose

Brain Injuries

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Novel MRI scan - 7 days post injury
Novel MRI scan - 14 days post injury
Functional MRI scan - 6 months post brachial plexus exploration
Functional MRI scan - 12 months post brachial plexus exploration
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St James's University Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with traumatic brachial plexus injuries

Arm 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2019
Last Updated
August 14, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04058821
Brief Title
Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
Official Title
Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aims are: Investigate new magnetic resonance imaging (MRI) scans for diagnosing severe nerve injury in the arm. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with traumatic brachial plexus injuries
Arm Type
Experimental
Arm 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Novel MRI scan - 7 days post injury
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Novel MRI scan - 14 days post injury
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional MRI scan - 6 months post brachial plexus exploration
Intervention Description
Continuous whole brain echo-planar imaging High-resolution T1-weighted imaging of the brain Bilateral magnetic resonance spectroscopy (12 minutes)
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional MRI scan - 12 months post brachial plexus exploration
Intervention Description
Continuous whole brain echo-planar imaging High-resolution T1-weighted imaging of the brain Bilateral magnetic resonance spectroscopy (12 minutes)
Primary Outcome Measure Information:
Title
Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus
Description
diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus
Time Frame
7 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryckie Wade
Phone
0113 392 3355
Email
ryckiewade@nhs.net
Facility Information:
Facility Name
St James's University Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

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