NCT04271449

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3.9 years until next milestone

Study Start

First participant enrolled

January 17, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

September 10, 2019

Last Update Submit

January 17, 2024

Conditions

Keywords

prismatic adaptationtDCS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Movement velocities of pointing trajectories

    Day 0

  • Movement directions of pointing trajectories

    Day 0

Study Arms (3)

Cerebellum tDCS

EXPERIMENTAL

Cerebellum tDCS arm will be subdivided into two other arms according to the polarity of the stimulation (inhibitory vs excitatory stimulation). These two subgroups will be divided into two other subgroups according the the task exposed during prism exposure (pointing vs throwing).

Device: tDCS (transcranial direct current stimulation)

Primary motor cortex

EXPERIMENTAL

Primary motor cortex tDCS arm will be subdivided into two other arms according to the polarity of the stimulation (inhibitory vs excitatory stimulation). These two subgroups will be divided into two other subgroups according the the task exposed during prism exposure (pointing vs throwing).

Behavioral: Virtual reality device

Sham tDCS

SHAM COMPARATOR

Sham tDCS arm will serve as a sham comparator for other experimental conditions. This arm will be subdivided into two groups depending on the localisation of the electrodes (cerebellum placement vs primary motor cortex placement).These two subgroups will be divided again in two subgroups depending on the task exposed (pointing vs throwing).

Device: tDCS (transcranial direct current stimulation)

Interventions

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.

Cerebellum tDCS

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.

Primary motor cortex

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Right-handed
  • Aged 18 to 70
  • Normal or corrected vision
  • Signed written informed consent
  • Affiliated to a health care organism.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct

Bron, 69500, France

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Yves ROSSETTI

    Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

February 17, 2020

Study Start

January 17, 2024

Primary Completion

January 17, 2024

Study Completion

January 17, 2024

Last Updated

January 18, 2024

Record last verified: 2023-01

Locations