NCT02976298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

September 2, 2025

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

March 26, 2013

Last Update Submit

August 25, 2025

Conditions

Transcranial Magnetic Stimulation

Keywords

cerebellumsupplementary motor area

Outcome Measures

Primary Outcomes (1)

  • postural control during gait initiation

    braking capacity

    change between baseline and 5 minutes after transcranial magnetic stimulation

Secondary Outcomes (1)

  • duration of anticipatory postural adjustments

    change between baseline and 5 minutes after transcranial magnetic stimulation

Other Outcomes (4)

  • centre of foot pressure displacement during postural adjustments

    change between baseline and 5 minutes after transcranial magnetic stimulation

  • step length

    change between baseline and 5 minutes after transcranial magnetic stimulation

  • step velocity

    change between baseline and 5 minutes after transcranial magnetic stimulation

  • +1 more other outcomes

Study Arms (3)

transcranial magnetic stimulation

SHAM COMPARATOR

sham transcranial magnetic stimulation

Other: transcranial magnetic stimulation

supplementary motor area stimulation

EXPERIMENTAL

supplementary motor area transcranial magnetic stimulation

Other: transcranial magnetic stimulation

cerebellar stimulation

EXPERIMENTAL

cerebellar transcranial magnetic stimulation

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulationOTHER

comparison of different conditions of transcranial magnetic stimulation

cerebellar stimulationsupplementary motor area stimulationtranscranial magnetic stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.L.Welter

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 28673716BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Marie-Laure Welter, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

  • Sabine Meunier, MD, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

November 29, 2016

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 2, 2025

Record last verified: 2016-11

Locations

FR(1)