Cerebello-thalamo-cortical Coupling in Essential Tremor

NCT ID: NCT02346409

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-04
• Study Completion Date: 2018-02-16

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.

Conditions

Essential Tremor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LFP-MEG recording with 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.

Group Type: EXPERIMENTAL

tACS of the cerebellum

Intervention Type: DEVICE

tACS of the cerebellum

tACS of the cerebellum vs VIM-DBS

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).

Group Type: ACTIVE_COMPARATOR

tACS of the cerebellum

Intervention Type: DEVICE

tACS of the cerebellum

Interventions

tACS of the cerebellum

tACS of the cerebellum

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICM

Paris, , France

Countries

France

References

Olivier C, Lamy JC, Kosutzka Z, Van Hamme A, Cherif S, Lau B, Vidailhet M, Karachi C, Welter ML. Cerebellar Transcranial Alternating Current Stimulation in Essential Tremor Patients with Thalamic Stimulation: A Proof-of-Concept Study. Neurotherapeutics. 2023 Jul;20(4):1109-1119. doi: 10.1007/s13311-023-01372-6. Epub 2023 Apr 25.

Reference Type: BACKGROUND

PMID: 37097344 (View on PubMed)

Other Identifiers

2014-A01393-44

Identifier Type: REGISTRY

Identifier Source: secondary_id

C14-44

Identifier Type: -

Identifier Source: org_study_id