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

Transcranial Magnetic Stimulation Clinical Trial

— CERESMARCHE  

Official title:

Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976298
• Other study ID #: C12-05
• Secondary ID: 2012-A00796-37
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 26, 2013
• Last updated: December 6, 2016
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Transcranial Magnetic Stimulation

Intervention

Other:
• transcranial magnetic stimulation
comparison of different conditions of transcranial magnetic stimulation

Locations

Country	Name	City	State
France	M.L.Welter	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	step length	step length	change between baseline and 5 minutes after transcranial magnetic stimulation	No
Other	step velocity	step velocity	change between baseline and 5 minutes after transcranial magnetic stimulation	No
Other	duration of electromyographic activity of the tibialis anterior muscles		change between baseline and 5 minutes after magnetic transcranial stimulation	No
Primary	postural control during gait initiation	braking capacity	change between baseline and 5 minutes after transcranial magnetic stimulation	No
Secondary	duration of anticipatory postural adjustments	duration	change between baseline and 5 minutes after transcranial magnetic stimulation	No