Cerebello-thalamo-cortical Coupling in Essential Tremor

Essential Tremor Clinical Trial

— CERESTIM  

Official title:

Cerebello-thalamo-cortical Coupling in Essential Tremor: Effects of High Frequency tACS of the Cerebellum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346409
• Other study ID #: C14-44
• Secondary ID: 2014-A01393-44
• Status: Completed
• Phase: N/A
• Start date: February 4, 2015
• Est. completion date: February 16, 2018

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of postural tremor of the upper limbs that impairs most of the manual activities of every day life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not fully elucidated, tremor is associated with abnormal activity within different brain regions, in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but is an invasive procedure. Transcranial stimulation of the cerebellum may represent a non-invasive therapeutic option for ET patients. Here, the investigators propose to test the efficacy of cerebellar stimulation in 15 ET patients previously operated for DBS of the thalamus. To further understand how this treatment provokes tremor reduction, the investigators will analyse the brain neuronal activity in 13 others ET patients candidate to thalamic DBS by using combined electrophysiological recordings of the thalamus (with the electrodes implanted), the cerebellum and the cortex with magnetoencephalography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 16, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age below 75 years

• diagnosis of essential tremor according to the criteria of the Tremor Investigation Group and the Consensus statement of the Movement Disorder Society Group (ref)

• health insurance

• signed informed written consent

Exclusion Criteria:

• other neurological disorders

• medications that interact with or influence brain excitability

• significant brain lesions detected in MRI

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• tACS of the cerebellum
tACS of the cerebellum

Locations

Country	Name	City	State
France	ICM	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
Primary	The neuronal activity in the cerebello-thalamo-cortical pathway	LFP, MEG and EMG activity recordings	1 day