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

Primary Purpose

Essential Tremor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tACS of the cerebellum
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Essential Tremor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ICM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LFP-MEG recording with tACS of the cerebellum

tACS of the cerebellum vs VIM-DBS

Arm 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.

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).

Outcomes

Primary Outcome Measures

The neuronal activity in the cerebello-thalamo-cortical pathway
LFP, MEG and EMG activity recordings

Secondary Outcome Measures

Full Information

First Posted
January 5, 2015
Last Updated
August 24, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02346409
Brief Title
Cerebello-thalamo-cortical Coupling in Essential Tremor
Acronym
CERESTIM
Official Title
Cerebello-thalamo-cortical Coupling in Essential Tremor: Effects of High Frequency tACS of the Cerebellum
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2015 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
February 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFP-MEG recording with tACS of the cerebellum
Arm Type
Experimental
Arm 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.
Arm Title
tACS of the cerebellum vs VIM-DBS
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
tACS of the cerebellum
Intervention Description
tACS of the cerebellum
Primary Outcome Measure Information:
Title
The neuronal activity in the cerebello-thalamo-cortical pathway
Description
LFP, MEG and EMG activity recordings
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
ICM
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

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Cerebello-thalamo-cortical Coupling in Essential Tremor

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