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
About this trial
This is an interventional basic science trial for Essential Tremor
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
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
NCT ID
NCT02346409
First Posted
January 5, 2015
Last Updated
August 24, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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
Learn more about this trial
Cerebello-thalamo-cortical Coupling in Essential Tremor
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