- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073630
Contribution of the Cerebellum In Sensory-motor Adaptation Via Gamma Oscillations: the Case of Dystonia (GAMMA)
Contribution du Cervelet Dans l'Adaptation Sensori-motrice Via Les Oscillations Gamma : le Cas de la Dystonie
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75651
- ICM GH Pitié Salpetrière
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Healthy subjects
healthy subjects will receive either sham or active cerebellar stimulation
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OTHER: Dystonia
dystonic patients will receive either sham or active cerebellar stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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. |
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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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
|
Collaborators and Investigators
Investigators
- Principal Investigator: sabine meunier, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C13-45
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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