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척수 손상이 있는 개인의 변형된 체현에 대한 종합 평가 (SCI_Embodiment)

2026년 11월 9일 업데이트: Swiss Paraplegic Research, Nottwil

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).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

80

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Canton of Lucerne
      • Nottwil, Canton of Lucerne, 스위스, 6207
        • Swiss Paraplegic Research

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Individuals with spinal cord injury and healthy controls.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: CASE_CONTROL
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Score on the Body Feelings and Illusions questionnaire (BoFI)
기간: Baseline

A questionnaires that assess different dimensions of embodiment and disembodiment.

Baseline

2차 결과 측정

결과 측정
측정값 설명
기간
Brain activity
기간: Baseline

Brain activity defined as changes in oxygen levels in the blood during the execution of the embodiment task, and at rest.

Baseline
Strenght of the embodiment illusion
기간: Baseline

Strenght of the embodiment illusion during the fMRI procedures, measured through a Likert scale.

Baseline
Qualitative assessment of embodiment
기간: Baseline

Qualitative assessment of the experience of embodiment by means of a semi-structured interview.

Baseline
Score on the WHO Disability Assessment Scale (WHODAS-II)
기간: Baseline

A scale that assesses activity limitation and participation restriction in the daily life due to disability.

Baseline
Pain severity
기간: Baseline

Intensity of pain measured on a visual analogue scale.

Baseline
Score on the Positive and Negative Affect Schedule (PANAS)
기간: Baseline

A scale which measures positive and negative sensations over the course of the last week.

Baseline
Anxiety score on the Hospital Anxiety and Depression Scale (HADS)
기간: Baseline

A scale the assesses the presence and the intensity of anxiety and depressive symptoms.

Baseline
Depression score on the Hospital Anxiety and Depression Scale (HADS)
기간: Baseline

A scale the assesses the presence and the intensity of anxiety and depressive symptoms.

Baseline
Score on the Pittsburgh Sleep Quality Index
기간: Baseline

A questionnaire assessing the quality of sleep.

Baseline
Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
기간: Baseline

A questionnaire assessing interoceptive awarness.

Baseline
Score on the Inclusion of Others in the Self test (IOS)
기간: Baseline

A questionnaire assessing the relationship of the individual self with other entities (e.g., the body, the famiy, the society).

Baseline
Score on the Montreal Cognitive Assessment (MoCA)
기간: Baseline

A test assessing cognitive functions such as memory, attention, language, and executive functions.

Baseline
Score on the Satisfaction with Life Scale (SLS)
기간: Baseline

A scale assessing satisfaction in life.

Baseline
Motor symptoms severity
기간: Baseline

Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)

Baseline
Demographics
기간: Baseline

Demographic information such as age, sex and education level, as well as time since injury.

Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 6월 4일

기본 완료 (실제)

2026년 7월 30일

연구 완료 (실제)

2026년 7월 31일

연구 등록 날짜

최초 제출

2024년 11월 12일

QC 기준을 충족하는 최초 제출

2024년 11월 12일

처음 게시됨 (실제)

2024년 11월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2024-13

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .