Influence of Kinesiophobia on the Excitability of Connections Parieto-frontal During a Pointing Movement in Humans

NCT06125613 | Completed

• 1 other identifier: 2021-A02457-34
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Kinesiophobia; Motor Coordination or Function; Developmental Disorder; Transcranial Magnetic Stimulation; Pain, Acute

Keywords

Kinesiophobia; Parietal posterior cortex; Motor Coordination or Function; Developmental Disorder; Transcranial magnetic stimulation; Pain attempt

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  During TMS experiment

Secondary Outcomes (2)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Double pulse TMS method used to investigate the influence of the pIPS on M1 excitability. We set the ST intensity to evoke a 1mV MEP in the first dorsal interosseous muscle. The SC is applied at 90% of the MT on the pIPS. Our study involves two phases: Resting Phase: 10 single ST and 10 SC+ST doublets with a 4ms interstimulus interval. ST intensity is set to evoke a 1mV MEP, and SC is at 90% of the motor threshold. Movement Phase: Subjects perform a specific hand movement in response to colored light signals (green or red) projected on a screen. A brief but non-painful stimulus may coincide with the red signal to induce a fear response. A test stimulus (ST) or SC+ST doublet is delivered with a 500ms delay after each signal, allowing us to explore corticocortical influences during motor programming. 40 stimulations in total are delivered during this phase. Note that only 40 trials will be performed, and there will be no painful stimuli.

Behavioral: Experimental

Interventions

Experimental BEHAVIORAL

In reality, there will not be 200 trials but 40, and no painful stimulus will be delivered. The objective is only to make the subject afraid of making a movement when the red stimulus appears, and for us to compare the situation "afraid to move" to that where there is no reason to be afraid in terms of corticocortical influences. The subject will then be invited, during the second experimental series, to perform the movements previously described. Whether the preparatory signal for movement is red or green, it will be followed with a delay of 500ms by a test stimulus alone (ST) or by a doublet of SC+ST stimulation. This stimulation will therefore occur during the motor programming period during which it has been shown in the literature that the pIPS exerts a facilitatory action on the primary motor cortex at a latency of 4 ms. In total, 10 ST and 10 SC-ST doublets will be delivered during the experimental series for each of the two colors, i.e. 40 stimulations in total.

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universite du Littoral Cote d'Opale: lead

Study Sites (1)

Neurophysiologie clinique Hôpital Roger Salengro / CHU

Lille, Nord, 59037, France

Location

MeSH Terms

Conditions

Kinesiophobia; Developmental Disabilities; Acute Pain

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A randomized number is allocated for all participants.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-post

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: December 10, 2021
• Primary Completion: March 8, 2023
• Study Completion: December 31, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)