Innovative Brain Stimulation for Induction of Learning Plasticity

Healthy Clinical Trial

Official title:

Effects of rTMS on Brain Plasticity and Motor Learning in Healthy People.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140994
• Other study ID #: Project-ID 2019-01440 CCER
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: October 2019
• Source: University of Geneva, Switzerland
• Contact: Pierre Nicolo, PhD
• Phone: +41 (0)22 372 38 76
• Email: pierre.nicolo[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Pierre Nicolo	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motor performance in retention test	Difference in error rate and speed improvement in active and sham groups (learned task)	After training (Day 2)
Other	Motor performance in transfer test	Difference in error rate and speed improvement in active and sham groups (non-learned) task)	after training (Day 2 and Day 3)
Primary	Motor performance in consolidation test	Difference in error rate and speed improvement in active and sham groups (learned task)	after training (Day 3)
Secondary	Resting state EEG connectivity in active and sham groups	Calculated from electroencephalography recordings	Before (Day 1) and after training (Day 2)
Secondary	Motor Evoked Potential (MEPs) Amplitudes (peak to peak)	Difference in MEPs between active and sham groups. MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles (Abductor pollicis brevis ).	Before (Day 1) and after training (Day 2)