Clinical trial NCT02976298: Effects of Cerebellum or Supplementary Motor Area Functional Inactivation on Gait and Balance Control
Official title: Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Transcranial Magnetic Stimulation
Keywords: cerebellum
supplementary motor area
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: postural control during gait initiation
timeFrame: change between baseline and 5 minutes after transcranial magnetic stimulation
Secondary outcomes:
measure: duration of anticipatory postural adjustments
timeFrame: change between baseline and 5 minutes after transcranial magnetic stimulation
Other outcomes:
measure: centre of foot pressure displacement during postural adjustments
timeFrame: change between baseline and 5 minutes after transcranial magnetic stimulation
measure: step length
timeFrame: change between baseline and 5 minutes after transcranial magnetic stimulation
measure: step velocity
timeFrame: change between baseline and 5 minutes after transcranial magnetic stimulation
measure: duration of electromyographic activity of the tibialis anterior muscles
timeFrame: change between baseline and 5 minutes after magnetic transcranial stimulation
Locations:
city: Paris
country: France
facility: M.L.Welter
Study officials:
affiliation: APHP
name: Marie-Laure Welter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Sabine Meunier, MD, PhD
role: STUDY_DIRECTOR
References: