Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries
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.
調査の概要
状態
条件
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Leeds、イギリス、LS9 7TF
- 募集
- St James's University Hospitals NHS Trust
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus
時間枠：7 mins
|
diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus
|
7 mins
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。