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

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ClinicalTrials.gov Identifier: NCT02346409
Recruitment Status : Unknown
Verified August 2017 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : January 27, 2015
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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 : February 4, 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018


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




Primary Outcome Measures :
  1. The neuronal activity in the cerebello-thalamo-cortical pathway [ Time Frame: 1 day ]
    LFP, MEG and EMG activity recordings



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346409


Contacts
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Contact: Marie-Laure Welter +33142162461
Contact: Jean-Charles Lamy

Locations
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France
ICM Recruiting
Paris, France, 75013
Contact: Marie-Laure Welter    +33142162461      
Contact: Jean-Charles Lamy    +33142165772      
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02346409     History of Changes
Other Study ID Numbers: C14-44
2014-A01393-44 ( Registry Identifier: IDRCB )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases