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临床试验/NCT06125613
NCT06125613已完成不适用

Influence de la kinésiophobie Sur l'excitabilité Des Connexions pariéto- Frontales au Cours d'un Mouvement de Pointage Chez l'Homme

Universite du Littoral Cote d'Opale2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Influence of induced kinesiophobia on the functional connectivity between the posterior parieto-occipital region and the primary motor cortex in healthy subjects during a pointing task.

研究概览

简要总结

Objective(s) of the trial: Better understand the interaction between kinesiophobia and motor control. Main objective: To measure the influence of induced kinesiophobia on functional connectivity between the posterior parieto-occipital region and the primary motor cortex in healthy subjects during a pointing task.

Secondary objectives: The secondary objectives will be 1) to verify the excitatory influence of pIPS stimulation on the excitability of M1 at rest and 2) to establish whether there is a correlation between functional connectivity and the level of kinesiophobia ( as measured by the Tampa Scale)

详细描述

This work will focus on a population of 30 healthy volunteer subjects who will be recruited via a posting within the Faculty of Sports Sciences of Lille, the University of Littoral Côte d'Opale and Eurasport. Compensation of 50 euros per subject is provided for participation in the study.

All these criteria will be reviewed during the visit to the clinical neurophysiology department during which each subject will be seen in an interview with a neurologist (Pr. Arnaud Delval, PU-PH of the clinical neurophysiology department of Lille University Hospital) before the start of the investigations. Explorations may be stopped at any time upon simple request from the participant. Each subject may leave the study by decision of the competent administrative authority, the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested party himself in accordance with the regulations and as mentioned in the consent. The data recorded in subjects who decide to leave the study will be partial and not exploitable, it will therefore be destroyed.

In this study, the impact of induced kinesiophobia on the functional connectivity between the PPC (posterior parietal cortex) and M1 (primary motor cortex) in healthy subjects during the preparatory phase of a pointing task will be assessed. Participants will undergo three transcranial magnetic stimulation (TMS) sessions.

The first session will be designed to define the optimal inter-stimulus intervals (ISIs) between both paired-pulses, with the conditioned stimulus (CS) applied to the PPC and the test stimulus (TS) applied to the M1. The second session will aim to define the optimal delay between the pointing start command (indicated by light signals) and the TS pulse over M1. The last session will determine whether a pointing start command related to a threat (indicated by a red light signal) has a different impact than a neutral pointing start command (indicated by a green light signal) on the functional connectivity between the PPC and M1.

To assess the personality of participants concerning kinesiophobia and fear-avoidance, participants will respond to two online questionnaires using RedCap, the Research Electronic Data Capture system. The questionnaires include the Tampa Scale for Kinesiophobia French version (TSK-CF) and the Fear-Avoidance Components Scale French version (FACS-Fr).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

A randomized number is allocated for all participants.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men and women
  • Healthy subjects (who do not have self-reported neurological disorders)
  • Subjects having signed informed consent (having a good command of French)
  • Subjects affiliated or beneficiaries of a social security system

排除标准

  • Psychiatric history obtained by questioning the doctor: people with mental retardation or severe impairment of cognitive, behavioral or affective functions prevents understanding the protocol and signing the informed consent
  • Neurological history (epilepsy, stroke, operations performed on the brain or spinal cord and history of neurological diseases affecting motor skills and sensitivity)
  • Subjects for whom we are unable to receive informed information (dementia, hearing problems, insufficient mastery of French etc.)
  • Contraindications to TMS (epilepsy, intracranial metallic foreign bodies, hearing aids or cochlear implants)
  • Taking psychotropic medications
  • Persons under guardianship or curatorship
  • Pregnant and breastfeeding women
  • Subjects with a cardiac pacemaker

结局指标

主要结局

Influence of induced kinesiophobia on the functional connectivity between the posterior parieto-occipital region and the primary motor cortex in healthy subjects during a pointing task.

时间窗: During TMS experiment

We will measure the amplitude of the motor response evoked by TMS in the first dorsal interosseous muscle during simple stimulation (test stimulus or ST) of the left primary motor cortex in the area controlling the muscles of the right hand, and when the Test stimulus is preceded by a conditioning stimulus (CS) applied to the left pIPS. We will then calculate the ratio between the response obtained in the double-shock condition (SC-ST) with an interstimulus interval of 4 ms and that obtained in response to the ST alone. This will be our main judgment criterion.

次要结局

  • Excitatory influence of pIPS stimulation on M1 excitability at rest(During TMS experiment)
  • Establish whether there is a correlation between functional connectivity and the level of kinesiophobia (as measured by the EKT)(Just before TMS experiment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Herve DEVANNE, PhD

Principal Investigator

Universite du Littoral Cote d'Opale

研究点 (2)

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