Brain InjuriesNCT04058821
Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
A study testing Novel MRI scan - 7 days post injury, Novel MRI scan - 14 days post injury and Functional MRI scan - 6 months post brachial plexus exploration in people with Brain Injuries, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Novel MRI scan - 7 days post injury, Novel MRI scan - 14 days post injury and Functional MRI scan - 6 months post brachial plexus exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St James's University Hospitals NHS Trust
Leeds, LS9 7TF
About this study
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.
Read more
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
- Being tested
- 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
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel MRI scan - 7 days post injuryDiagnostic test
- 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)
Novel MRI scan - 14 days post injuryDiagnostic test
- 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)
Functional MRI scan - 6 months post brachial plexus explorationDiagnostic test
- Continuous whole brain echo-planar imaging
- High-resolution T1-weighted imaging of the brain
- Bilateral magnetic resonance spectroscopy (12 minutes)
Functional MRI scan - 12 months post brachial plexus explorationDiagnostic test
- Continuous whole brain echo-planar imaging
- High-resolution T1-weighted imaging of the brain
- Bilateral magnetic resonance spectroscopy (12 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Adults with traumatic brachial plexus injuries | Experimental | 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start29 Jan 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058821
- Sponsor's protocol ID
- PL18/110632
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
- ClinicalTrials.gov ID
- NCT04058821
- Acronym / sponsor ID
- PL18/110632
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with traumatic brachial plexus injuries | Experimental | 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 explorationParticipants will have two MRI scans before surgery (to find out the best time to scan), then two after surgery (at 6 and 12 months). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Adults with traumatic brachial plexus injuries |
| 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 | Adults with traumatic brachial plexus injuries |
| 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 | Adults with traumatic brachial plexus injuries |
| 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) | Diagnostic test | Adults with traumatic brachial plexus injuries |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel MRI scan - 7 days post injury, Novel MRI scan - 14 days post injury and Functional MRI scan - 6 months post brachial plexus exploration in people with Brain Injuries, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryckie Wade (0113 392 3355, ryckiewade@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus (time frame: 7 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.