Effects of Cerebellum or Supplementary Motor Area Functional Inactivation on Gait and Balance Control (CERESMARCHE)

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.

Study Overview

• Status: Completed
• Conditions: Transcranial Magnetic Stimulation
• Intervention / Treatment: Other: transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • M.L.Welter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-70 years
• agree to participate to the study with signature of the informed consent
• heathy insurance
• normal clinical exam

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: transcranial magnetic stimulation; sham transcranial magnetic stimulation	Other: transcranial magnetic stimulation; comparison of different conditions of transcranial magnetic stimulation
Experimental: supplementary motor area stimulation; supplementary motor area transcranial magnetic stimulation	Other: transcranial magnetic stimulation; comparison of different conditions of transcranial magnetic stimulation
Experimental: cerebellar stimulation; cerebellar transcranial magnetic stimulation	Other: transcranial magnetic stimulation; comparison of different conditions of transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postural control during gait initiation	braking capacity	change between baseline and 5 minutes after transcranial magnetic stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of anticipatory postural adjustments	duration	change between baseline and 5 minutes after transcranial magnetic stimulation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
centre of foot pressure displacement during postural adjustments	centre of foot pressure displacement measured by force platform	change between baseline and 5 minutes after transcranial magnetic stimulation
step length	step length	change between baseline and 5 minutes after transcranial magnetic stimulation
step velocity	step velocity	change between baseline and 5 minutes after transcranial magnetic stimulation
duration of electromyographic activity of the tibialis anterior muscles		change between baseline and 5 minutes after magnetic transcranial stimulation

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Study Director: Sabine Meunier, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France; Principal Investigator: Marie-Laure Welter, MD, PhD, APHP

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimated): November 29, 2016

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: cerebellum; supplementary motor area
• Additional Relevant MeSH Terms: Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: C12-05; 2012-A00796-37 (Registry Identifier: IDRCB)