Cerebello-thalamo-cortical Coupling in Essential Tremor

NCT02346409 | Completed

• 2 other identifiers: C14-442014-A01393-44
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The neuronal activity in the cerebello-thalamo-cortical pathway

  LFP, MEG and EMG activity recordings

  1 day

Study Arms (2)

LFP-MEG recording with tACS of the cerebellum

EXPERIMENTAL

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.

Device: tACS of the cerebellum

tACS of the cerebellum vs VIM-DBS

ACTIVE COMPARATOR

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).

Device: tACS of the cerebellum

Interventions

tACS of the cerebellum DEVICE

tACS of the cerebellum

LFP-MEG recording with tACS of the cerebellum; tACS of the cerebellum vs VIM-DBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other neurological disorders
• medications that interact with or influence brain excitability
• significant brain lesions detected in MRI

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

ICM

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 37097344 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 27, 2015
• Study Start: February 4, 2015
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2018
• Last Updated: August 29, 2025

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)