Healthy VolunteersTRANSTIMNCT04271449
tDCS and Prismatic Adaptation: Roles of the Cerebellum and the Primary Motor Cortex in the Transfer of After-effects
A study testing tDCS (transcranial direct current stimulation) and Virtual reality device in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- tDCS (transcranial direct current stimulation) and Virtual reality device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2024to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Right-handed
- Aged 18 to 70
- Normal or corrected vision
- Signed written informed consent
- Affiliated to a health care organism.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct
Bron, 69500
About this study
Official title: tDCS and Prismatic Adaptation: Roles of the Cerebellum and the Primary Motor Cortex in the Transfer of After-effects to a Non-exposed Task.
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- tDCS (transcranial direct current stimulation), Virtual reality device
- Keywords
- prismatic adaptation, tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS (transcranial direct current stimulation)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.
Virtual reality deviceBehavioural
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.
tDCS (transcranial direct current stimulation)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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: tDCS (transcranial direct current stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (2)
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start17 Jan 2024
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Why it stopped: no inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ROSSETTI, Principal investigator, Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271449
- Sponsor's protocol ID
- 69HCL19_0485
- Other IDs
- 2019-A02373-54
- Acronym
- TRANSTIM
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS and Prismatic Adaptation: Roles of the Cerebellum and the Primary Motor Cortex in the Transfer of After-effects to a Non-exposed Task.
- ClinicalTrials.gov ID
- NCT04271449
- Acronym / sponsor ID
- TRANSTIM / 69HCL19_0485
- Conditions
- Healthy Volunteers
- Keywords
- prismatic adaptation, tDCS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cerebellum tDCS | Experimental | Device: tDCS (transcranial direct current stimulation)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). |
| Primary motor cortex | Experimental | Behavioral: Virtual reality devicePrimary 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). |
| Sham tDCS | Sham comparator | Device: tDCS (transcranial direct current stimulation)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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Right-handed
- Aged 18 to 70
- Normal or corrected vision
- Signed written informed consent
Key exclusion criteria (7 listed)
- Neurological or psychiatric disorder
- Pregnancy
- Epilepsy antecedents
- Presence of metallic implant, pace maker, cochlear implant, chirurgical brain clip.
- Cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cerebellum tDCS |
| Virtual reality deviceNon 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. | Behavioural | Primary motor cortex |
| 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. | Device | Sham tDCS |
Primary outcome
Endpoint lateral errors : lateral distance between the endpoint of the movement and the aimed target assessed by motion capture.
Time frame: Day 0
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.
2 secondary outcomes
Movement velocities of pointing trajectories
Time frame: Day 0
Movement directions of pointing trajectories
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves ROSSETTI principal investigator
Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS (transcranial direct current stimulation) and Virtual reality device in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoint lateral errors : lateral distance between the endpoint of the movement and the aimed target assessed by motion capture. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.