Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04058821|
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
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
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
- Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus [ Time Frame: 7 mins ]diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058821
|Contact: Ryckie Wade||0113 392 firstname.lastname@example.org|
|St James's University Hospitals NHS Trust||Recruiting|
|Leeds, United Kingdom, LS9 7TF|