跳至主要内容
临床试验/NCT07203807
NCT07203807已完成不适用

Methodological Study on the Minimum Number of Blocks in fNIRS: Brain Activity During Voluntary Movement and During Illusory Movement Induced by Vibratory Tendon Stimulation of the Right Distal Upper Limb in Healthy Right-handed Participants

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2025年10月27日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Cerebral hemodynamic variations in the sensorimotor areas assessed by fNIRS with 42 long channels and 4 short channels.

研究概览

简要总结

The purpose of this study is to investigate the cerebral activation of healthy participants during a voluntary movement and an illusory movement induced by vibration.

This will be done by repeating both tasks 20 times for 10 seconds.

The study aims to determine the minimum number of repetitions (blocks) required to maximize cerebral activity.

详细描述

Functional near-infrared spectroscopy (fNIRS) is a non-invasive method that measures cortical hemodynamic responses by measuring variations in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR). Thanks to its portability, ease of use, and low cost, fNIRS is particularly well suited to the study of neurological populations such as stroke patients.

To obtain a robust hemodynamic response, fNIRS studies use a block-design experimental paradigm, alternating between periods of task performance and rest. However, there is considerable heterogeneity in the number of blocks used in the literature, making it difficult to construct an optimal paradigm. Among the methodological issues, knowledge of the minimum number of blocks for which the cerebral response is maximal appears to be a key point.

It is generally acknowledged that increasing the number of blocks reduces intra-individual variability and improves the detection of task-specific responses. However, increasing the number of blocks increases the acquisition time, which can lead to fatigue or discomfort, particularly in elderly participants or participants with neurological disorders. A compromise must be found between methodological precision and clinical tolerance in the construction of future experimental paradigms, particularly those involving a motor task in a neurological rehabilitation context.

To date, the literature does not recommend a specific number of blocks based on the actual motor task (voluntary movement) or illusory task (induced by tendon vibration stimulation (TVS)), as both modalities are used in rehabilitation. Improving our understanding of the relationship between the number of blocks and the hemodynamic response measured by fNIRS depending on the type of task would enable us to move towards standardizing experimental paradigms.

The aim of this study is to identify the minimum number of blocks required to obtain a maximal cerebral hemodynamic response (variations in HbO and HbR), measured by fNIRS during a unilateral hand motor task and an illusory movement induced by TVS in healthy participants. Ultimately, these results will help optimize fNIRS experimental paradigms by ensuring reliable capture of task-related brain activity in a minimum of time, compatible with a pathological population.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers aged 18 to 40
  • Right-handed: Edinburgh laterality test short format QL > 60 (Veale et al., 2014).
  • Sufficient command of the French language to understand instructions
  • No known neurological medical history

排除标准

  • Allergy to neoprene (fNIRS cap material)
  • Hair volume preventing the cap from fitting and/or access to the scalp
  • Injury to right upper limb causing pain during mobilization
  • Protected person (under guardianship or trusteeship)
  • Person under court protection
  • Persons deprived of liberty
  • Persons not affiliated to a social security scheme
  • Pregnant or breast-feeding women
  • Volunteers opposed to the study

结局指标

主要结局

Cerebral hemodynamic variations in the sensorimotor areas assessed by fNIRS with 42 long channels and 4 short channels.

时间窗: Day 0

HbO will be considered as the primary outcome measure of the cerebral activity through the hemodynamic response

Cerebral hemodynamic variations in the frontoparietal areas assessed by fNIRS with 42 long channels and 4 short channels

时间窗: Day 0

HbO will be considered as the primary outcome measure of the cerebral activity through the hemodynamic response

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验