Cerebello-thalamo-cortical Coupling in Essential Tremor

Not Applicable

Completed

• Conditions: Essential Tremor
• Interventions: Device: tACS of the cerebellum

• Registration Number: NCT02346409
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Study Start: 2015-02-04
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LFP-MEG recording with tACS of the cerebellum	tACS of the cerebellum	To explore how cerebellar stimulation (using tACS) will alter oscillations and coupling along the CTC pathway, relating these changes in brain activity to clinical improvement.
tACS of the cerebellum vs VIM-DBS	tACS of the cerebellum	To evaluate the differential effects of non invasive high-frequency stimulation tACS of the cerebellum, as compared to high-frequency stimulation of the thalamus (using DBS of the VIM).

Primary Outcome Measures

Name	Time	Method
The neuronal activity in the cerebello-thalamo-cortical pathway	1 day	LFP, MEG and EMG activity recordings

Trial Locations

Locations (1)

ICM; 🇫🇷 Paris, France