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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04271449
Other study ID # 69HCL19_0485
Secondary ID 2019-A02373-54
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 17, 2024
Est. completion date January 17, 2024

Study information

Verified date January 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Human beings are able to produce precise and smooth movements despite varying demands thank to the nervous system plasticity. Primastic exposure is a method that allows to easily study these sensorimotor plasticity processes in a laboratory context. In a typical protocol, participants wear prismatic goggles that induce a lateral deviation of the visual field while performing a goal directed motor task (e.g. pointing). During the first trials, participants make errors in the direction of the deviation and correct them trial-by-trial. Finally, participants go back to baseline performances after a few dozen of trials. Upon goggles removal, participants make mistakes toward the direction opposition to the initial prismatic deviation. These after-effects reflect adaptive processes that occurred to counteract the perturbation. The way that these after-effects can be transferred to other situations which have not been exposed to the prismatic perturbation bring crucial information about the nature of the processes involved. Additionally, these transfer properties might be of great interest in the field of neuro rehabilitation. In fact, the purpose of therapeutic strategies is to induce compensations that can be transferred to daily life situations. In previous studies, the investigator showed that expertise on the exposed had a notable influence on transfer properties. However, these studies did not allow to identify the cerebral regions involved in transfer. The cerebellum is described as a major area implied during motor adaptation and the occurrence of after-effects, while the primary motor cortex might play a crucial role in the formation of motor memory. As such, these two regions are likely to be involved in transfer properties. The objective of this project is to identify the roles of the cerebellum and the primary motor cortex in the transfer of visuomotor compensations acquired during prism exposure to task that has not been practiced under the perturbation. To do so, the investigator will use transcranial direct current stimulation (tDCS) which is a non-painful and non-invasive functional brain stimulation method. Several groups will be constituted to test if stimulation (inhibitory and excitatory) of the cerebellum or the primary motor on the transfer of prism acquired compensations to a non-exposed task. More precisely, the investigator aim to study the influence of different stimulation modalities (cerebellum vs MA, inhibitory vs excitatory vs sham) on the error reduction during prism exposure, on the amount of after-effects and on the amount on transfer to the non-exposed task. On a fundamental level, this project will allow a better understanding of the sensorimotor plasticity processes involved to counteract a perturbation and about mechanisms underlying transfer properties. Future results would allows to shed light on the conditions necessary to give rise to transfer as well as the implied brain regions. On longer-term these results will be used to optimize rehabitation strategies in motor function recovery in order to favour the transfer of acquired compensations to daily life situations.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 17, 2024
Est. primary completion date January 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Male or female - Right-handed - Aged 18 to 70 - Normal or corrected vision - Signed written informed consent - Affiliated to a health care organism. Exclusion Criteria: - Neurological or psychiatric disorder - Pregnancy - Epilepsy antecedents - Presence of metallic implant, pace maker, cochlear implant, chirurgical brain clip. - Cognitive disorders - presence of corrective eyeglasses - Right upper limb orthopedic disorders

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS (transcranial direct current stimulation)
Non invasive functional brain stimulation that allows to modulate the excitability of a targeted area (inhibitory or excitatory) thanks to a small current that goes beyond two electrodes. For this arm, the targeted are will be the cerebellum. Prismatic googles will also be used in the same way in all groups during prism exposure.
Behavioral:
Virtual reality device
Non invasive functional brain stimulation that allows to modulate the excitability of a targeted area (inhibitory or excitatory) thanks to a small current that goes beyond two electrodes. For this arm, the targeted are will be the cerebellum. Prismatic googles will also be used in the same way in all groups during prism exposure.
Device:
tDCS (transcranial direct current stimulation)
Non invasive functional brain stimulation that allows to modulate the excitability of a targeted area (inhibitory or excitatory) thanks to a small current that goes beyond two electrodes. For this arm, the targeted are will be either the cerebellum or the primary motor cortex, but the stimulation will be turned off after 15 seconds to insure a sham condition. Prismatic googles will also be used in the same way in all groups during prism exposure.

Locations

Country Name City State
France Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endpoint lateral errors : lateral distance between the endpoint of the movement and the aimed target assessed by motion capture. Primary outcome measure will be the endpoint lateral error for each trial, that will be expressed in degrees. The distance between the aimed target and either the final position of the index (pointing trials) or the ball impact (throwing trials) will be recorded with a motion capture system and expressed in centimeters. Then, they will be converted into degrees through trignometric rules, taking in account the distance between the eyes and the target. Day 0
Secondary Movement velocities of pointing trajectories Movement velocities (cm/s) at acceleration, velocity and deceleration peaks. Kinematics will be calculated using positions of markers on the arm, recorded by motion capture. Day 0
Secondary Movement directions of pointing trajectories Movement movement directions (orientation of velocity vectors in degrees) at acceleration, velocity and deceleration peaks. Kinematics will be calculated using positions of markers on the arm, recorded by motion capture. Day 0
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