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Completed

NCT Number: NCT02073630

Contribution of the Cerebellum In Sensory-motor Adaptation Via Gamma Oscillations: the Case of Dystonia

Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal and human experiments that the cerebellum plays a prominent role in the pathophysiology of dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia, resulting in a decoupling of the motor component from the afferent information flow resulting from changes in the environment. An overall loss of gabaergic-mediated inhibition is at the forefront in dynamic changes in neural circuitry described in dystonia. In the mature brain gabaergic control the generation of temporal synchronies and oscillations in the glutamatergic neurons. Taken these all together with the results of a pilot experiment, the investigators hypothesize that deficient synchronies in the fast gamma range are one of the key mechanisms leading to abnormal communication inside the cerebello-cortical network in dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma oscillations in the nodes of the cerebello-cortical network. The investigators then aim to re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the cerebellum at high gamma frequency a non invasive transcranial alternative current stimulation.

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Key information

Conditions

Primary Dystonia Central Nervous System Diseases Dystonic Disorders Movement Disorders Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICM GH Pitié Salpetrière

Paris, 75651, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary upper limb dystonia
  • normal physical and neurological examination except for dystonia
  • no treatment with botulinum toxin during the three months preceding the study

Exclusion criteria

  • Writing tremor
  • current neurological or psychiatric illness other than dystonia
  • uncontrollable medical problems not related to dystonia
  • pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control

Treatment and study plan

active cerebellar stimulation

Other

sham cerebellar stimulation

Other

Primary outcomes

  1. change in gamma oscillations power in the cerebellum during a sensorimotor adaptation task

    Time frame: measures will be done at each of 3 visits: visit1, visit2 at expected average 7 days after visit1 and visit3 at expected average 14 days after visit1

    MEG recording will be performed using a whole-head 306-channels MEG system (Elekta Neuromag® TriuxTM System) comprising 204 planar gradiometers and 102 magnetometers regularly distributed at 102 locations over the scalp. MEG data will be coregistered with the structural MRI of each subject using BrainStorm (http://neuroimage.usc.edu/brainstorm).

    The localization of the source will be constrained with the individual anatomy obtained with MRI.

Secondary outcomes

  1. synchrony in the gamma band between the cerebellum and the sensorimotor cortex

    Time frame: measures will be done at each of 3 visits: visit1, visit2 at expected average 7 days after visit1 and visit3 at expected average 14 days after visit1

    We will also conduct a functional connectivity analysis to assess the neuronal interactions between the cerebellum and the thalamus, the thalamus and the motor cortex by quantifying correlations between power envelopes. We will compute Pearson's linear correlation between the power envelopes from two different locations (between couples of magnetometers and couples of nodes at the source level).

Other outcomes

  1. behavioral performances at a sensorimotor adaptation task

    Time frame: measures will be done at each of 3 visits: visit1, visit2 at expected average 7 days after visit1 and visit3 at expected average 14 days after visit1

    Subjects will have to reach six different targets positioned on a half-circle and appearing in a predictable order on a computer screen by moving a amagnetic joystick with their right hand. During the direct condition, there will be a direct coupling between the joystick and the cursor position. During the indirect conditions, 4 different rotations between the joystick and the cursor positions will be introduced. During one session the shifts will be 10°, 30°, -20°, -40° and in the other session -10°, -30°, 20°, 40° in order to reduce possible skill transfer from the baseline session to the stimulation session. Indirect and direct trials will be randomized to avoid habituation and learning within a session. There will be 2 blocks of 160 trials. In each block, there will be 20 trials for each rotation and 80 trials of the direct condition

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

Contribution du Cervelet Dans l'Adaptation Sensori-motrice Via Les Oscillations Gamma : le Cas de la Dystonie

Acronym: GAMMA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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