Trials / Unknown
UnknownNCT04058821
Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- The Leeds Teaching Hospitals NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2019-01-29
- Primary completion
- 2019-09-30
- Completion
- 2019-09-30
- First posted
- 2019-08-16
- Last updated
- 2019-08-16
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04058821. Inclusion in this directory is not an endorsement.