NCT02073630

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

February 19, 2014

Last Update Submit

October 31, 2017

Conditions

Keywords

magnetoencephalographynon invasive brain stimulationcerebellumgamma rhythms

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

OTHER

healthy subjects will receive either sham or active cerebellar stimulation

Other: active cerebellar stimulationOther: sham cerebellar stimulation

Dystonia

OTHER

dystonic patients will receive either sham or active cerebellar stimulation

Other: active cerebellar stimulationOther: sham cerebellar stimulation

Interventions

DystoniaHealthy subjects
DystoniaHealthy subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • sabine meunier, MD, PhD

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

    PRINCIPAL INVESTIGATOR

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

Locations