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Trial record 1 of 1 for:    NCT02073630
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Contribution of the Cerebellum In Sensory-motor Adaptation Via Gamma Oscillations: the Case of Dystonia (GAMMA)

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ClinicalTrials.gov Identifier: NCT02073630
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE February 19, 2014
First Posted Date  ICMJE February 27, 2014
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE February 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Contribution of the Cerebellum In Sensory-motor Adaptation Via Gamma Oscillations: the Case of Dystonia
Official Title  ICMJE Contribution du Cervelet Dans l'Adaptation Sensori-motrice Via Les Oscillations Gamma : le Cas de la Dystonie
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Primary Dystonia
Intervention  ICMJE
  • Other: active cerebellar stimulation
  • Other: sham cerebellar stimulation
Study Arms  ICMJE
  • Healthy subjects
    healthy subjects will receive either sham or active cerebellar stimulation
    Interventions:
    • Other: active cerebellar stimulation
    • Other: sham cerebellar stimulation
  • Dystonia
    dystonic patients will receive either sham or active cerebellar stimulation
    Interventions:
    • Other: active cerebellar stimulation
    • Other: sham cerebellar stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2017)
63
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2014)
40
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02073630
Other Study ID Numbers  ICMJE C13-45
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: sabine meunier, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP