Transcranial Magnetic StimulationPhase 1/2CERESMARCHENCT02976298
Effects of Cerebellum or Supplementary Motor Area Functional Inactivation on Gait and Balance Control
A Phase 1/2 study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
In human, the physiology of gait and balance is not clearly established. By using functional imaging and electrophysiological techniques, various brain regions from the cortex to the midbrain area, including the cerebellum, have been identified as involved in such control. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Magnetic Stimulation
- What is being tested?
- transcranial magnetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jan 2015
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years
- agree to participate to the study with signature of the informed consent
- heathy insurance
- normal clinical exam
Who cannot join
- previous medical history of neurological, rheumatological, orthopedic or psychiatric disorders
- contra-indication to MRI or TMS
- drug treatment that modifies the nervous central system excitability (antidepressant, antiepileptic, neuroleptic)
- chronic alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme
In human, the physiology of gait and balance is not clearly established. By using functional imaging and electrophysiological techniques, various brain regions from the cortex to the midbrain area, including the cerebellum, have been identified as involved in such control. The specific role of these structures in both the capacity to go forward (locomotion) and stand upright (balance), but also in the different phases of the gait initiation process, are not known, however. In this study,the investigators aimed to assess the specific role of both the supplementary motor area (SMA) and the cerebellum in postural control during the initiation of gait. For this purpose, the investigators plan to study the gait initiation in 20 healthy subjects before and after functional inactivation (using inhibitory repetitive transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic and electromyographic parameters of the gait initiation will be recorded using a force platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG electrodes.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- transcranial magnetic stimulation
- Keywords
- cerebellum, supplementary motor area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationOther
comparison of different conditions of transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| transcranial magnetic stimulation | Sham comparator | sham transcranial magnetic stimulation Receives: Other: transcranial magnetic stimulation |
| supplementary motor area stimulation | Experimental | supplementary motor area transcranial magnetic stimulation Receives: Other: transcranial magnetic stimulation |
| cerebellar stimulation | Experimental | cerebellar transcranial magnetic stimulation Receives: Other: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural control during gait initiation
braking capacity
Measured: change between baseline and 5 minutes after transcranial magnetic stimulation
Secondary outcomes (1)
duration of anticipatory postural adjustments
duration
Measured: change between baseline and 5 minutes after transcranial magnetic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startFeb 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marie-Laure Welter, MD, PhD, Principal investigator, APHPSabine Meunier, MD, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976298
- Sponsor's protocol ID
- C12-05
- Other IDs
- 2012-A00796-37
- Acronym
- CERESMARCHE
- Status last verified
- Nov 2016
- First submitted
- 26 Mar 2013
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Richard A, Van Hamme A, Drevelle X, Golmard JL, Meunier S, Welter ML. Contribution of the supplementary motor area and the cerebellum to the anticipatory postural adjustments and execution phases of human gait initiation. Neuroscience. 2017 Sep 1;358:181-189. doi: 10.1016/j.neuroscience.2017.06.047. Epub 2017 Jul 1.
PubMed 28673716
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme
- ClinicalTrials.gov ID
- NCT02976298
- Acronym / sponsor ID
- CERESMARCHE / C12-05
- Conditions
- Transcranial Magnetic Stimulation
- Keywords
- cerebellum, supplementary motor area
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Feb 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
In human, the physiology of gait and balance is not clearly established. By using functional imaging and electrophysiological techniques, various brain regions from the cortex to the midbrain area, including the cerebellum, have been identified as involved in such control. The specific role of these structures in both the capacity to go forward (locomotion) and stand upright (balance), but also in the different phases of the gait initiation process, are not known, however. In this study,the investigators aimed to assess the specific role of both the supplementary motor area (SMA) and the cerebellum in postural control during the initiation of gait. For this purpose, the investigators plan to study the gait initiation in 20 healthy subjects before and after functional inactivation (using inhibitory repetitive transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic and electromyographic parameters of the gait initiation will be recorded using a force platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG electrodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| transcranial magnetic stimulation | Sham comparator | Other: transcranial magnetic stimulationsham transcranial magnetic stimulation |
| supplementary motor area stimulation | Experimental | Other: transcranial magnetic stimulationsupplementary motor area transcranial magnetic stimulation |
| cerebellar stimulation | Experimental | Other: transcranial magnetic stimulationcerebellar transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-70 years
- agree to participate to the study with signature of the informed consent
- heathy insurance
- normal clinical exam
Key exclusion criteria (4 listed)
- previous medical history of neurological, rheumatological, orthopedic or psychiatric disorders
- contra-indication to MRI or TMS
- drug treatment that modifies the nervous central system excitability (antidepressant, antiepileptic, neuroleptic)
- chronic alcoholism
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 |
|---|---|---|
| transcranial magnetic stimulationcomparison of different conditions of transcranial magnetic stimulation | Other | cerebellar stimulation, supplementary motor area stimulation, transcranial magnetic stimulation |
Primary outcome
postural control during gait initiation
Time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
braking capacity
1 secondary outcome
duration of anticipatory postural adjustments
Time frame: change between baseline and 5 minutes after transcranial magnetic stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Results publication: PubMed 28673716Richard A, Van Hamme A, Drevelle X, Golmard JL, Meunier S, Welter ML. Contribution of the supplementary motor area and the cerebellum to the anticipatory postural adjustments and execution phases of human gait initiation. Neuroscience. 2017 Sep 1;358:181-189. doi: 10.1016/j.neuroscience.2017.06.047. Epub 2017 Jul 1.
Related trials for Transcranial Magnetic Stimulation
Recruiting
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Modeling of Recruitment Curves
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
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.
Marie-Laure Welter, MD, PhD principal investigator
APHP
Sabine Meunier, MD, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 France. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postural control during gait initiation (time frame: change between baseline and 5 minutes after transcranial magnetic stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976298, which also lists 1 linked publication.
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 2 Sep 2025.