Clinical trial NCT04140994: Innovative Brain Stimulation for Induction of Learning Plasticity
Official title: Effects of rTMS on Brain Plasticity and Motor Learning in Healthy People.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Motor performance in consolidation test
timeFrame: after training (Day 3)
Secondary outcomes:
measure: Resting state EEG connectivity in active and sham groups
timeFrame: Before (Day 1) and after training (Day 2)
measure: Motor Evoked Potential (MEPs) Amplitudes (peak to peak)
timeFrame: Before (Day 1) and after training (Day 2)
Other outcomes:
measure: Motor performance in retention test
timeFrame: After training (Day 2)
measure: Motor performance in transfer test
timeFrame: after training (Day 2 and Day 3)
Locations:
city: Geneva
country: Switzerland
facility: Pierre Nicolo
Study officials:
affiliation: University Hospital, Geneva
name: Adrian Guggisberg, Prof. Dr.
role: STUDY_DIRECTOR
References: