NCT04140994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 24, 2019

Last Update Submit

October 25, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Motor performance in consolidation test

    Difference in error rate and speed improvement in active and sham groups (learned task)

    after training (Day 3)

Secondary Outcomes (2)

  • Resting state EEG connectivity in active and sham groups

    Before (Day 1) and after training (Day 2)

  • Motor Evoked Potential (MEPs) Amplitudes (peak to peak)

    Before (Day 1) and after training (Day 2)

Other Outcomes (2)

  • Motor performance in retention test

    After training (Day 2)

  • Motor performance in transfer test

    after training (Day 2 and Day 3)

Study Arms (2)

Intermittent theta burst stimulation

ACTIVE COMPARATOR

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

Sham intermittent theta burst stimulation

SHAM COMPARATOR

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

Device: rTMS device

Interventions

rTMS deviceDEVICE

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.

Intermittent theta burst stimulationSham intermittent theta burst stimulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pierre Nicolo

Geneva, 1211, Switzerland

RECRUITING

Study Officials

  • Adrian Guggisberg, Prof. Dr.

    University Hospital, Geneva

    STUDY DIRECTOR

Central Study Contacts

Pierre Nicolo, PhD

CONTACT

+41 (0)22 372 38 76pierre.nicolo@hcuge.ch

Pierre Nicolo, PhD

CONTACT

+41792633543nicolopierre@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

October 24, 2019

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

CH(1)