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

I

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

Status and phase

Completed
Phase 2
Phase 1

Conditions

Transcranial Magnetic Stimulation

Treatments

Other: transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02976298
2012-A00796-37 (Registry Identifier)
C12-05

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 3 patient groups

transcranial magnetic stimulation
Sham Comparator group
Description:
sham transcranial magnetic stimulation
Treatment:
Other: transcranial magnetic stimulation
supplementary motor area stimulation
Experimental group
Description:
supplementary motor area transcranial magnetic stimulation
Treatment:
Other: transcranial magnetic stimulation
cerebellar stimulation
Experimental group
Description:
cerebellar transcranial magnetic stimulation
Treatment:
Other: transcranial magnetic stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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