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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 6, 2017
August 1, 2016
2 years
February 19, 2014
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in gamma oscillations power in the cerebellum during a sensorimotor adaptation task
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 Outcomes (1)
synchrony in the gamma band between the cerebellum and the sensorimotor cortex
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 Outcomes (1)
behavioral performances at a sensorimotor adaptation task
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
Study Arms (2)
Healthy subjects
OTHERhealthy subjects will receive either sham or active cerebellar stimulation
Dystonia
OTHERdystonic patients will receive either sham or active cerebellar stimulation
Interventions
Eligibility Criteria
You may qualify if:
- primary upper limb dystonia
- normal physical and neurological examination except for dystonia
- no treatment with botulinum toxin during the three months preceding the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICM GH Pitié Salpetrière
Paris, 75651, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sabine meunier, MD, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 27, 2014
Study Start
February 1, 2014
Primary Completion
February 1, 2016
Study Completion
August 1, 2016
Last Updated
November 6, 2017
Record last verified: 2016-08