CERESTIM: Cerebello-thalamo-cortical Coupling in Essential Tremor

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT02346409

Collaborator

(none)

Enrollment

Location

Arms

36.4

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Tremor	Device: tACS of the cerebellum	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Cerebello-thalamo-cortical Coupling in Essential Tremor: Effects of High Frequency tACS of the Cerebellum

Actual Study Start Date :

Feb 4, 2015

Actual Primary Completion Date :

Feb 16, 2018

Actual Study Completion Date :

Feb 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: tACS of the cerebellum tACS of the cerebellum
Active Comparator: 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).	Device: tACS of the cerebellum tACS of the cerebellum

Arm

Intervention/Treatment

Experimental: 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.

Device: tACS of the cerebellum

tACS of the cerebellum

Active Comparator: 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).

Device: tACS of the cerebellum

tACS of the cerebellum

Outcome Measures

Primary Outcome Measures

The neuronal activity in the cerebello-thalamo-cortical pathway [1 day]
LFP, MEG and EMG activity recordings

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICM	Paris		France	75013

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02346409

Other Study ID Numbers:

C14-44
2014-A01393-44

First Posted:

Jan 27, 2015

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Additional relevant MeSH terms:

Tremor

Essential Tremor

Study Results

No Results Posted as of Aug 30, 2021