Cerebellum and Cortical Plasticity: the Case of Dystonia (CERDYS)

August 27, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Purpose

- Objective : Sensorimotor adaptation allows the modification of the motor command taking into account the errors detected during execution of prior movements. It involves a large cortico-subcortical network. Isolated lesions of this network do not systematically alter sensorimotor adaptation except for cerebellar lesions. The cerebellum is thus a key structure for sensorimotor adaptation. However, the link between cerebellar and the cortical plasticity underlying sensorimotor adaptation remain unknown. Alteration of sensorimotor adaptation is associated with dystonia but it is unclear whether it is a cause or consequence of dystonia. It has been hypothesized that the abnormal plasticity observed in dystonia could account for the associated alteration of sensorimotor adaptation.

Classically, basal ganglia dysfunction is considered to be crucial for dystonia pathogenesis. However, recent studies suggest that the involvement of the cerebellum may also be important in this setting. In primary dystonia, imaging studies showed abnormal cerebellar activation during sensorimotor adaptation tasks and neurophysiological studies demonstrated a decrease of cerebellar output.

The aim of this study is to investigate the role of the cerebellum in the cortical plasticity underlying sensorimotor adaptation both in healthy subjects (normal plasticity) and in dystonic patients (abnormal plasticity).

- Methods: Paired associative stimulation PAS consists in repetitive pairing of a peripheral nerve and a cortical stimulation. This kind of stimulation has been designed to induce artificial plasticity that can be easily measured. This PAS induced sensorimotor plasticity is exacerbated and has lost its topographical specificity in dystonic patients.TMS using trains of TMS pulses (rTMS) can be applied on the cerebellum to modulate its output. We will test the effect of rTMS induced modulation (cTBS- inhibitory, iTBS-excitatory, sham) of the cerebellar output on PAS induced plasticity in patients with dystonia and healthy control.

We will also assess the acute effect of the rTMS induced modulation of the cerebellar output on the dystonic symptoms and on the performance at a validated sensorimotor adaptation task. This will be done by double blind post-hoc scoring of the dystonia (BFM or TWSTRS) on standardized videorecording and measurement of the performance at the task after each rTMS session (cTBS, iTBS, sham).

Finally, we will assess the variation of PAS effect on other parameters reflecting cortical excitability after each rTMS session (cTBS, iTBS, sham).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hpôpital Pitié Sapétrière - U 975 Plate forme " Pole Exploration de l'homme : Gait, Equilibrium, Posture, and Movement "

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

All subjects

  • Age >18 years and < 70 years
  • Normal physical and neurological examination, except for dystonia (when present)
  • No treatment with botulinum toxin during the last three months
  • No treatment altering the cortical excitability
  • Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential

Primary focal dystonia group

  • Patients with cervical and/or upper limb dystonia
  • No cause of secondary dystonia

Secondary dystonia group

• Cervical dystonia and/or upper limb dystonia History of perinatal anoxia

Exclusion criteria

  • MMS ≤ 24/30
  • Current neurological or psychiatric illness other than dystonia.
  • Individual who is on medication which is known to lower seizure threshold (see lists above), or who has a pacemaker, an implanted medical pump, a metal plate, a metal plate or metal object in the skull or eye (for example after brain surgery) will be excluded
  • Uncontrollable medical problems not related to dystonia such as; cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease
  • Previous history of seizure(s) or current active epilepsy
  • Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
  • Patients legally protected
  • Patients who are not enrolled at social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy volunteers
Other: Transcranial magnetic stimulation
Transcranial magnetic stimulation (PAS and rTMS)
Experimental: Primary cervical dystonia Patients
Other: Transcranial magnetic stimulation
Transcranial magnetic stimulation (PAS and rTMS)
Experimental: Primary upperlimb Dystonia Patients
Other: Transcranial magnetic stimulation
Transcranial magnetic stimulation (PAS and rTMS)
Experimental: Secondary Cervical or Upperlimb Dystonia due to cerebral palsy
Other: Transcranial magnetic stimulation
Transcranial magnetic stimulation (PAS and rTMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of MEP0/MEP10 and MEP0/MEP30 values obtained after sham, cRTBS or iTBS of the cerebellum.
Time Frame: 6 weeks
The effect of rTMS induced modulation of the cerebellar output on the PAS induced plasticity will be assessed by measurement of the size variation of a 1mV test motor evoked potential (which reflect cortical excitability) before (MEP0) and 10 and 30 minutes (MEP10 and MEP30) after PAS. The primary outcome measure will be the comparison of MEP0/MEP10 and MEP0/MEP30 values obtained after sham, cRTBS or iTBS of the cerebellum.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the appropriate dystonic clinical score (depending on the type of dystonia) after each rTMS session (cTBS, iTBS, sham).
Time Frame: 6 weeks
The effect of rTMS induced modulation of the cerebellar output on dystonic symptoms will be assessed by the variation of the appropriate dystonic clinical score (depending on the type of dystonia) after each rTMS session (cTBS, iTBS, sham).
6 weeks
Measurement of number of errors, mean time to reach the target after each rTMS session (cTBS, iTBS, sham).
Time Frame: 6 weeks
The effect of rTMS induced modulation of the cerebellar output on the performance at the sensorimotor adaptation task will be assessed by measurement of number of errors, mean time to reach the target after each rTMS session (cTBS, iTBS, sham).
6 weeks
Measurement of the variation of the motor threshold, intracortical inhibition and intracortical facilitation after each rTMS session (cTBS, iTBS, sham).
Time Frame: 6 weeks
The effect of rTMS induced modulation of the cerebellar output on other parameter reflecting cortical excitability will be assessed by measurement of the variation of the motor threshold, intracortical inhibition and intracortical facilitation after each rTMS session (cTBS, iTBS, sham).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Sree Chitra Tirunal Institute for Medical Sciences & Technology
Policlinico G . Martino, Messina Italy

Investigators

  • Study Director: Emmanuel Roze, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France
  • Principal Investigator: Asha Kishore, MD, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST)
  • Principal Investigator: Margherita Russo, MD, Policlinico G . Martino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

October 24, 2012

Study Completion (Actual)

October 24, 2012

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimated)

January 7, 2011

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C10-01
  • 2010-A00931-38 (Registry Identifier: IDRCB)

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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