脊髄損傷者の身体変化の包括的評価 (SCI_Embodiment)
Spinal cord injury (SCI) occurs when trauma or other factors damage the spinal cord, disrupting the flow of sensory information from the body to the brain. This interruption can interfere with embodiment-the body awareness and physical sensations processed by the brain-sometimes leading to a phenomenon called disembodiment.
For people with SCI, disembodiment may appear as unusual body sensations, like feeling that a limb is in a different position than it actually is. Such changes in body awareness can impact daily life, mental health, and rehabilitation outcomes.
Despite its importance, the study of embodiment in SCI remains limited. This project aims to explore how SCI alters embodiment, focusing on its specific characteristics, the effects on daily life, and the underlying brain activity as measured by functional magnetic resonance imaging (fMRI). Both people with and without SCI will participate.
Procedure: Participants will complete a single examination lasting 2 to 2.5 hours, including approximately 55 minutes in the MRI scanner (with preparation and follow-up).
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Canton of Lucerne
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Nottwil、Canton of Lucerne、スイス、6207
- Swiss Paraplegic Research
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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
Individuals with spinal cord injury and healthy controls.
説明
Inclusion Criteria for all participants:
- Age between 18 and 60
- Normal or corrected-to-normal visual acuity
- German or Italian native speaker
Additional Inclusion Criteria only for individuals with SCI:
- Diagnosis of traumatic spinal cord injury
- Lesion level below T1 (first thoracic vertebra)
- Time since injury >= 12 months
- Residual sensation on the upper leg (sensory capability of 1 or higher on at least one leg in the dermatomes L2 and L3 for both light touch and pin prick).
Exclusion Criteria for all participants:
- Pregnancy or breastfeeding
- Diagnosis of other psychiatric or neurological disorders (e.g. epilepsy, tumor in the central nervous system)
- Confirmed diagnosis of alcohol and/or drug abuse with active consumption within the last 6 months
- Confirmed diagnosis of traumatic brain injury, intended as visible changes in the brain diagnosed by a radiologist
- Stroke
- Inability to perform study procedures (e.g. inability to consent)
Additional Exclusion Criteria for both HC and SCI undergoing the fMRI procedure:
- Active medical devices (e.g. cardiac pacemaker)
- Inability to perform study procedures (e.g. claustrophobia)
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 |
|---|---|
|
Individuals with SCI - Behavioral assessment
15 individuals with SCI will perform a comprehensive behavioral assessment of embodiment (see "Interventions"). A clinical assessment of sensory-motor symptoms will also be carried out. |
A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition. |
|
Individuals with SCI - Behavioral assessment and fMRI
25 individuals with SCI will perform a comprehensive behavioral assessment of embodiment and neural correlates of embodiment will be explored by means of an fMRI procedure (see "Interventions"). A clinical assessment of sensory-motor symptoms will also be carried out. |
A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition. Neural mechanisms of embodiments will be explored with MRI sequences including structural MRI, resting-state and task-based fMRI of the head. The task will be a modified version of the rubber hand illusion, previously used to asess embodiment. Participants will be required to lay in the MRI with their legs bended upright and a screen placed at the level of their hips, which will show a pair of legs. The participant's leg will be stroked with a paintbrush while the image on the screen will be showing the virtual legs being stroked. Participants will be required to report how strongly they perceive the virtual legs as their own, as a measure of embodiment. |
|
Healthy controls - Behavioral assessment
15 healthy controls will perform a comprehensive behavioral assessment of embodiment (see "Interventions"). |
A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition. |
|
Healthy controls - Behavioral assessment and fMRI
25 individuals with SCI will perform a comprehensive behavioral assessment of embodiment and neural correlates of embodiment will be explored by means of an fMRI procedure (see "Interventions"). |
A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition. Neural mechanisms of embodiments will be explored with MRI sequences including structural MRI, resting-state and task-based fMRI of the head. The task will be a modified version of the rubber hand illusion, previously used to asess embodiment. Participants will be required to lay in the MRI with their legs bended upright and a screen placed at the level of their hips, which will show a pair of legs. The participant's leg will be stroked with a paintbrush while the image on the screen will be showing the virtual legs being stroked. Participants will be required to report how strongly they perceive the virtual legs as their own, as a measure of embodiment. |
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 |
|---|---|---|
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Score on the Body Feelings and Illusions questionnaire (BoFI)
時間枠：Baseline
|
A questionnaires that assess different dimensions of embodiment and disembodiment. |
Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Brain activity
時間枠：Baseline
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Brain activity defined as changes in oxygen levels in the blood during the execution of the embodiment task, and at rest. |
Baseline
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Strenght of the embodiment illusion
時間枠：Baseline
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Strenght of the embodiment illusion during the fMRI procedures, measured through a Likert scale. |
Baseline
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Qualitative assessment of embodiment
時間枠：Baseline
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Qualitative assessment of the experience of embodiment by means of a semi-structured interview. |
Baseline
|
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Score on the WHO Disability Assessment Scale (WHODAS-II)
時間枠：Baseline
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A scale that assesses activity limitation and participation restriction in the daily life due to disability. |
Baseline
|
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Pain severity
時間枠：Baseline
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Intensity of pain measured on a visual analogue scale. |
Baseline
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Score on the Positive and Negative Affect Schedule (PANAS)
時間枠：Baseline
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A scale which measures positive and negative sensations over the course of the last week. |
Baseline
|
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Anxiety score on the Hospital Anxiety and Depression Scale (HADS)
時間枠：Baseline
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A scale the assesses the presence and the intensity of anxiety and depressive symptoms. |
Baseline
|
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Depression score on the Hospital Anxiety and Depression Scale (HADS)
時間枠：Baseline
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A scale the assesses the presence and the intensity of anxiety and depressive symptoms. |
Baseline
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Score on the Pittsburgh Sleep Quality Index
時間枠：Baseline
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A questionnaire assessing the quality of sleep. |
Baseline
|
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Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
時間枠：Baseline
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A questionnaire assessing interoceptive awarness. |
Baseline
|
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Score on the Inclusion of Others in the Self test (IOS)
時間枠：Baseline
|
A questionnaire assessing the relationship of the individual self with other entities (e.g., the body, the famiy, the society). |
Baseline
|
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Score on the Montreal Cognitive Assessment (MoCA)
時間枠：Baseline
|
A test assessing cognitive functions such as memory, attention, language, and executive functions. |
Baseline
|
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Score on the Satisfaction with Life Scale (SLS)
時間枠：Baseline
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A scale assessing satisfaction in life. |
Baseline
|
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Motor symptoms severity
時間枠：Baseline
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Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI) |
Baseline
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Demographics
時間枠：Baseline
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Demographic information such as age, sex and education level, as well as time since injury. |
Baseline
|
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 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- 2024-13
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The investigators plan to save anonymized data into public repositories. However, due to the size of the imaging data, a final decision has not yet been made.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。