DystoniaCERDYSNCT01272154
Cerebellum and Cortical Plasticity: the Case of Dystonia
A study testing Transcranial magnetic stimulation in people with Dystonia, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia
- What is being tested?
- Transcranial magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to 24 Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hpôpital Pitié Sapétrière - U 975 Plate forme " Pole Exploration de l'homme : Gait, Equilibrium, Posture, and Movement "
Paris, 75013
About this study
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.
Read more
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).
- Conditions
- Dystonia
- Being tested
- Transcranial magnetic stimulation
- Keywords
- Cerebellum, Cortical plasticity, Sensorimotor adaptation, Dystonia, Cerebral Palsy, Transcranial Magnetic Stimulation, and
- Medical subject headings
- Dystonia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationOther
Transcranial magnetic stimulation (PAS and rTMS)
| Study group | Role | What they receive |
|---|---|---|
| Primary cervical dystonia Patients | Experimental | Not described Receives: Other: Transcranial magnetic stimulation |
| Primary upperlimb Dystonia Patients | Experimental | Not described Receives: Other: Transcranial magnetic stimulation |
| Secondary Cervical or Upperlimb Dystonia due to cerebral palsy | Experimental | Not described Receives: Other: Transcranial magnetic stimulation |
| Healthy volunteers | Other | Not described Receives: Other: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of MEP0/MEP10 and MEP0/MEP30 values obtained after sham, cRTBS or iTBS of the cerebellum.
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.
Measured: 6 weeks
Secondary outcomes (3)
Variation of the appropriate dystonic clinical score (depending on the type of dystonia) after each rTMS session (cTBS, iTBS, sham).
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).
Measured: 6 weeks
Measurement of number of errors, mean time to reach the target after each rTMS session (cTBS, iTBS, sham).
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).
Measured: 6 weeks
Measurement of the variation of the motor threshold, intracortical inhibition and intracortical facilitation after each rTMS session (cTBS, iTBS, sham).
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion24 Oct 2012
- Study completion24 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Sree Chitra Tirunal Institute for Medical Sciences & Technology, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Responsible party
- Sponsor
- Investigators
- Emmanuel Roze, MD, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceAsha Kishore, MD, Principal investigator, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST)Margherita Russo, MD, Principal investigator, Policlinico G . Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272154
- Sponsor's protocol ID
- C10-01
- Other IDs
- 2010-A00931-38
- Acronym
- CERDYS
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2011
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hubsch C, Roze E, Popa T, Russo M, Balachandran A, Pradeep S, Mueller F, Brochard V, Quartarone A, Degos B, Vidailhet M, Kishore A, Meunier S. Defective cerebellar control of cortical plasticity in writer's cramp. Brain. 2013 Jul;136(Pt 7):2050-62. doi: 10.1093/brain/awt147.
PubMed 23801734
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellum and Cortical Plasticity: the Case of Dystonia
- ClinicalTrials.gov ID
- NCT01272154
- Acronym / sponsor ID
- CERDYS / C10-01
- Conditions
- Dystonia
- Keywords
- Cerebellum, Cortical plasticity, Sensorimotor adaptation, Dystonia, Cerebral Palsy, Transcranial Magnetic Stimulation, and
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Sree Chitra Tirunal Institute for Medical Sciences & Technology, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Study start
- Jan 2011 (actual)
- Primary completion
- 24 Oct 2012 (actual)
- Study completion
- 24 Oct 2012 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary cervical dystonia Patients | Experimental | Other: Transcranial magnetic stimulation |
| Primary upperlimb Dystonia Patients | Experimental | Other: Transcranial magnetic stimulation |
| Secondary Cervical or Upperlimb Dystonia due to cerebral palsy | Experimental | Other: Transcranial magnetic stimulation |
| Healthy volunteers | Other | Other: Transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationTranscranial magnetic stimulation (PAS and rTMS) | Other | Healthy volunteers, Primary cervical dystonia Patients, Primary upperlimb Dystonia Patients, Secondary Cervical or Upperlimb Dystonia due to cerebral palsy |
Primary outcome
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.
3 secondary outcomes
Variation of the appropriate dystonic clinical score (depending on the type of dystonia) after each rTMS session (cTBS, iTBS, sham).
Time frame: 6 weeks
Measurement of number of errors, mean time to reach the target after each rTMS session (cTBS, iTBS, sham).
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 23801734Hubsch C, Roze E, Popa T, Russo M, Balachandran A, Pradeep S, Mueller F, Brochard V, Quartarone A, Degos B, Vidailhet M, Kishore A, Meunier S. Defective cerebellar control of cortical plasticity in writer's cramp. Brain. 2013 Jul;136(Pt 7):2050-62. doi: 10.1093/brain/awt147.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Roze, MD, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
Asha Kishore, MD principal investigator
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST)
Margherita Russo, MD principal investigator
Policlinico G . Martino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Dystonia, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of MEP0/MEP10 and MEP0/MEP30 values obtained after sham, cRTBS or iTBS of the cerebellum. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.