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

NCT ID: NCT02976298

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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transcranial magnetic stimulation

sham transcranial magnetic stimulation

Group Type SHAM_COMPARATOR

transcranial magnetic stimulation

Intervention Type OTHER

comparison of different conditions of transcranial magnetic stimulation

supplementary motor area stimulation

supplementary motor area transcranial magnetic stimulation

Group Type EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type OTHER

comparison of different conditions of transcranial magnetic stimulation

cerebellar stimulation

cerebellar transcranial magnetic stimulation

Group Type EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type OTHER

comparison of different conditions of transcranial magnetic stimulation

Interventions

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transcranial magnetic stimulation

comparison of different conditions of transcranial magnetic stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Laure Welter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Sabine Meunier, MD, PhD

Role: STUDY_DIRECTOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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M.L.Welter

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 28673716 (View on PubMed)

Other Identifiers

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2012-A00796-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

C12-05

Identifier Type: -

Identifier Source: org_study_id

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