Cerebello-thalamo-cortical Coupling in Essential Tremor (CERESTIM)

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

Status: Completed

Conditions: Essential Tremor

Treatments: Device: tACS of the cerebellum

Study type: Interventional

Funder types: Other

Identifiers

NCT02346409

2014-A01393-44 (Registry Identifier)

C14-44

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

LFP-MEG recording with tACS of the cerebellum

Experimental group

Description:

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.

Treatment:

Device: tACS of the cerebellum

tACS of the cerebellum vs VIM-DBS

Active Comparator group

Description:

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).

Treatment:

Device: tACS of the cerebellum