HealthyNCT04140994
Innovative Brain Stimulation for Induction of Learning Plasticity
A study testing rTMS device in people with Healthy, run by University of Geneva, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- rTMS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Oct 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- man or woman aged between 18-40 years,
- ability to give informed consent,
- ability to follow protocol instructions,
- normal or corrected-to-normal vision,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Pierre Nicolo
Geneva, 1211
Pierre Nicolo, 0792633543, pierre.nicolo@hcuge.ch
About this study
Official title: Effects of rTMS on Brain Plasticity and Motor Learning in Healthy People.
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- rTMS device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: rTMS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance in consolidation test
Difference in error rate and speed improvement in active and sham groups (learned task)
Measured: after training (Day 3)
Secondary outcomes (2)
Resting state EEG connectivity in active and sham groups
Calculated from electroencephalography recordings
Measured: Before (Day 1) and after training (Day 2)
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 ).
Measured: Before (Day 1) and after training (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start24 Oct 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Nicolo, University of Geneva, Switzerland
- Investigators
- Adrian Guggisberg, Prof. Dr., Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140994
- Sponsor's protocol ID
- Project-ID 2019-01440 CCER
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of rTMS on Brain Plasticity and Motor Learning in Healthy People.
- ClinicalTrials.gov ID
- NCT04140994
- Acronym / sponsor ID
- Project-ID 2019-01440 CCER
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta burst stimulation | Active comparator | Device: rTMS deviceVolunteers 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. |
| Sham intermittent theta burst stimulation | Sham comparator | Device: rTMS deviceFor sham iTBS, the protocol is the same, except the sham coil produces no magnetic field. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- man or woman aged between 18-40 years,
- ability to give informed consent,
- ability to follow protocol instructions,
- normal or corrected-to-normal vision,
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS deviceParticipants 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. | Device | Intermittent theta burst stimulation, Sham intermittent theta burst stimulation |
Primary outcome
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)
2 secondary outcomes
Resting state EEG connectivity in active and sham groups
Time frame: Before (Day 1) and after training (Day 2)
Motor Evoked Potential (MEPs) Amplitudes (peak to peak)
Time frame: Before (Day 1) and after training (Day 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Guggisberg, Prof. Dr. study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS device in people with Healthy, run by University of Geneva, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Nicolo, PhD (+41 (0)22 372 38 76, pierre.nicolo@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor performance in consolidation test (time frame: after training (Day 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.