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Innovative Brain Stimulation for Induction of Learning Plasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04140994
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pierre Nicolo, University of Geneva, Switzerland

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.

Condition or disease Intervention/treatment Phase
Healthy Device: rTMS device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of rTMS on Brain Plasticity and Motor Learning in Healthy People.
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Active Comparator: 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.

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.

Sham Comparator: Sham intermittent theta burst stimulation
For sham iTBS, the protocol is the same, except the sham coil produces no magnetic field.
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.




Primary Outcome Measures :
  1. Motor performance in consolidation test [ Time Frame: after training (Day 3) ]
    Difference in error rate and speed improvement in active and sham groups (learned task)


Secondary Outcome Measures :
  1. Resting state EEG connectivity in active and sham groups [ Time Frame: Before (Day 1) and after training (Day 2) ]
    Calculated from electroencephalography recordings

  2. Motor Evoked Potential (MEPs) Amplitudes (peak to peak) [ Time Frame: Before (Day 1) and after training (Day 2) ]
    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 ).


Other Outcome Measures:
  1. Motor performance in retention test [ Time Frame: After training (Day 2) ]
    Difference in error rate and speed improvement in active and sham groups (learned task)

  2. Motor performance in transfer test [ Time Frame: after training (Day 2 and Day 3) ]
    Difference in error rate and speed improvement in active and sham groups (non-learned) task)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140994


Contacts
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Contact: Pierre Nicolo, PhD +41 (0)22 372 38 76 pierre.nicolo@hcuge.ch
Contact: Pierre Nicolo, PhD +41792633543 nicolopierre@gmail.com

Locations
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Switzerland
Pierre Nicolo Recruiting
Geneva, Switzerland, 1211
Contact: Pierre Nicolo    0792633543    pierre.nicolo@hcuge.ch   
Sponsors and Collaborators
University of Geneva, Switzerland
Investigators
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Study Director: Adrian Guggisberg, Prof. Dr. University Hospital, Geneva

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Responsible Party: Pierre Nicolo, Principal Investigator, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT04140994    
Other Study ID Numbers: Project-ID 2019-01440 CCER
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No