切断後のCNSの変化
中枢神経系の損傷後の中枢神経系の機能的、構造的、代謝的変化
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following congenital upper limb loss. The focus is on the brain's sensory processing and how neuronal changes may relate to clinical measures. By doing so, the hope is to gain insight into the contribution of critical periods to the plasticity of the sensorimotor processing stream. Both macroscopic and microscopic changes of the brain will be examined in individuals with upper limb amelia and compared to healthy controls. fMRI will be combined with behavioural testing to understand which clinical and behavioural determinants drive somatosensory representations along the entire somatosensory processing stream. Using advanced imaging techniques, the aim is to investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, gain a better understanding of the mechanistic underpinnings of functional reorganisation. Overall, the hope is to provide the first mechanistic insight into whether early life experiences are crucial for the development of the relay nuclei in the central nervous system and how these changes relate to clinical measures such as adaptive behaviours or pain.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Paige Howell, PhD
- 電話番号:+41 44 632 32 94
- メール:paige.howell@hest.ethz.ch
研究連絡先のバックアップ
- 名前:Sanne Kikkert
- 電話番号:+41 44 632 32 94
- メール:sanne.kikkert@balgrist.ch
研究場所
-
-
Canton of Zurich
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Zurich、Canton of Zurich、スイス、8008
- 募集
- Balgrist Campus
-
コンタクト:
- Paige Howell, PhD
- 電話番号:+41 44 632 32 94
- メール:paige.howell@hest.ethz.ch
-
-
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
サンプリング方法
調査対象母集団
Patients with an upper-limb amputation and healthy subjects.
説明
Inclusion Criteria - Patients:
- Age 18-75
- Upper-limb congenital amputees with complete absence of a hand
- Signed informed consent
Exclusion Criteria - Patients:
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI > 40
- Pregnancy
- Claustrophobia
Inclusion Criteria - Healthy subjects:
- Age 18-75
- Signed Informed consent
Exclusion Criteria - Healthy subjects:
- Contraindications to magnetic resonance imaging
- Pregnancy
- Neurological illness
- Impairment of body function induced by a congenital upper-limb amputation
- Claustrophobia
- BMI > 40
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
- 観測モデル:CASE_CONTROL
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
健常者
|
Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function Use of functional and structural MRI in both the brain and the spinal cord and questionnaires. |
|
先天性切断患者
|
Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function Use of functional and structural MRI in both the brain and the spinal cord and questionnaires. |
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 |
|---|---|---|
|
Change of functional MRI (fMRI) parameter between 2 to 4 time points
時間枠:Up to 50 weeks
|
Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in patients with congenital amputations and compared to healthy controls |
Up to 50 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Conventional magnetic resonance imaging (MRI) parameter
時間枠:Up to 50 weeks
|
Structural characteristics in the brain and cervical spinal cord are assessed in patients with congenital upper-limb amputations using conventional MRI and compared to healthy controls |
Up to 50 weeks
|
|
Amputees: Motor Activity Log questionnaire
時間枠:Up to 50 weeks
|
Evaluation of residual limb and/or prosthesis usage as compared to other body parts via a questionnaire and behavioural assessments. |
Up to 50 weeks
|
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 (推定)
研究の完了 (推定)
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。