Innovative Brain Stimulation for Induction of Learning Plasticity

NCT ID: NCT04140994

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2020-05-01

Brief Summary

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Recent studies have identified new neurobiological biomarker (i.e. functional connectivity of the parietal cortex) of motor learning among healthy people. This enables to refine our current model of motor learning wherein specific cortical processes are key factors for motor acquisition. Furthermore, recent evidence suggests that new technical approaches such as repetitive magnetic stimulation (rTMS) can efficiently influence this key factor. However, up to now, no rTMS studies have target this new biomarker. Therefore, the effect of rTMS are unknown. Hence, the investigators want to develop a new rTMS setup able to induce specific brain processes in healthy individuals that are likely to benefit. This has the potential to obtain critical information in order to improve treatment of motor re-learning in patients with neurological diseases.

Detailed Description

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Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of rTMS) coupled with motor learning. Participants will be randomly assigned to one of 2 groups: real iTBS over parietal cortex and sham iTBS over the parietal cortex.

One day before (Day1) and after the motor learning (Day 2), participants will undergo high-density 128-channel resting state electroencephalography (EEG) and motor evoked potential (MEP) in order to characterize the effects of rTMS on our markers of plasticity. Performance on the task will be measure immediately after learning (Day 2) and again 24h later (Day 3) in order to test for retention and offline consolidation (time and errors). The task will consist in realizing a computerized mirror-drawing task, in which right-left movements of the mouse were reversed on the screen.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intermittent theta burst stimulation

Volunteers will be submitted to non-invasive parietal stimulation before a mirror drawing task.

A transcranial magnetic stimulator (MagPro X100, Medtronic Functional Diagnostics, Skovlunde, Denmark) will deliver interrmittent bursts of bipolar magnetic pulses exerting an excitation on the underlying brain tissue (iTBS). The stimulation coil will be placed over the parietal cortex. Stimulation consisted of a burst of three pulses administered at 50Hz, repeated at a frequency of 5Hz, delivered in 2 s trains followed by an 8 s interval for a total of 600 pulses12. Stimulation intensity was set at 70% of RMT.

Each session will consist of two spaced neuronavigated iTBS applications, separated by 15 minutes.

Group Type ACTIVE_COMPARATOR

rTMS device

Intervention Type DEVICE

Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of TMS) coupled with motor learning.

Sham intermittent theta burst stimulation

For sham iTBS, the protocol is the same, except the sham coil produces no magnetic field.

Group Type SHAM_COMPARATOR

rTMS device

Intervention Type DEVICE

Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of TMS) coupled with motor learning.

Interventions

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rTMS device

Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of TMS) coupled with motor learning.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* man or woman aged between 18-40 years,
* ability to give informed consent,
* ability to follow protocol instructions,
* normal or corrected-to-normal vision,

Exclusion Criteria

* history of epileptic seizure (ci. TMS),
* skull breach (ci. TMS),
* metallic object in the brain (ci. TMS),
* pacemaker (ci. TMS),
* severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases),
* pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Geneva, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Pierre Nicolo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Guggisberg, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital, Geneva

Locations

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Pierre Nicolo

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Pierre Nicolo, PhD

Role: CONTACT

+41 (0)22 372 38 76

Pierre Nicolo, PhD

Role: CONTACT

+41792633543

Facility Contacts

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Pierre Nicolo

Role: primary

0792633543

Other Identifiers

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Project-ID 2019-01440 CCER

Identifier Type: -

Identifier Source: org_study_id

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