Wilson DiseaseWILSTIMNCT01980433
Inhibitory rTMS in Dystonic Wilson Patients
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), pre and post-rTMS electroencephalogram and WCRS in people with Wilson Disease and Movement Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. The neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wilson Disease, Movement Disorders, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), pre and post-rTMS electroencephalogram and WCRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wilson disease with focal right hand dystonia
- No modification of medical treatment for 6 months
- No botulinum toxin administration within the past four months
- Right handed
- Focal right hand dystonia
- Cerebral Magnetic Resonance performed the last 6 months with no other lesion than met in Wilson disease
Show all 9Show fewer
- Over 18
- Insurance policy holder
- Informed consent
Who cannot join
- Pregnant woman
- Guardianship procedure
- Seizure history
- Other cerebral lesions on cerebral MRI than met in Wilson Disease
- Unable to stay quiet for 30 minutes
- Handwriting impossible
- Contra-indications to repetitive Transcranial Magnetic Stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation
Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. The neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily life activities such as writing, which is particularly disabling, since writing is the only mean of communication in these patients with significant slurred speech. Treatment is limited and only partially effective.
Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown inhibiting properties when applied over the cortex. Since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right dystonic hand, assessed immediately at the end of the session.
Read the detailed description
This study investigates the handwriting performance of an homogeneous cohort of patients with Wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial magnetic stimulation (rTMS). Fifteen patients with focal right hand dystonia will receive randomly either active or sham rTMS (1 Hz) to the left somatosensory cortex (SSC) in one single 20 minutes session. Handwriting performance will be measured immediately after this unique session (Visual analogic scale of subjective discomfort in writing, DPRE and WCRS scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24 hours before the session. Three days later, the patient will receive the other session (sham rTMS or active rTMS) and the same parameters will be evaluated.
This is a single-center, randomized, crossover, prospective, clinical and double-blind study (the rTMS session is performed by the neurophysiologist, but the patient and the neurologist who will perform the handwriting evaluation are blind to the session).
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), pre and post-rTMS electroencephalogram, WCRS, handwriting scale DPRE, visual analog scale of discomfort writing and parameters collected on touchpad
- Keywords
- Wilson disease, Dystonia, Movement Disorders, Handwriting, Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Hepatolenticular Degeneration, Movement Disorders, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.
pre and post-rTMS electroencephalogramOther
to verify the absence of infraclinical seizures
WCRSOther
Writer's cramp rating scale
handwriting scale DPREOther
handwriting in development and being evaluated by the NRC Wilson
visual analog scale of discomfort writing and parameters collected on touchpadOther
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Other: pre and post-rTMS electroencephalogram; Other: WCRS; Other: handwriting scale DPRE; Other: visual analog scale of discomfort writing and parameters collected on touchpad |
| Sham rTMS | Sham comparator | Placebo Transcranial Magnetic stimulation delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Other: pre and post-rTMS electroencephalogram; Other: WCRS; Other: handwriting scale DPRE; Other: visual analog scale of discomfort writing and parameters collected on touchpad |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate and significant improvement in writing
Improvement of handwriting performance immediately after one single 20 minutes session of inhibitory (1 Hz) repetitive transcranial magnetic stimulation over the left somatosensory cortex.
quantitative test score of writing WCRS
Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
Measured: up to 1 week
Secondary outcomes (3)
significant improvement in writing
improvement of other quantitative test scores of writing (VAS subjective discomfort writing, DPRE scales and parameters measured on touchpad) after a single session of 1 Hz rTMS inhibitory to the left CSS , compared to the scores achieved in the 24 hours before the session of rTMS.
Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
Measured: up to 1 week
improvement of dystonia on the scale WDRS
Assessing the improvement of dystonia on the scale WDRS after a single session of 1 Hz rTMS inhibitory to the left CSS, compared to the scores achieved in the 24 hours before the session of rTMS.
Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
Measured: up to 1 week
correlation between the scores and the other parameters of disease severity
Assess whether age, disease duration and the presence of cortical atrophy are inversely correlated with the evolution of scores.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie KUBIS, MD, PhD, Study director, Physiology Department, Lariboisière HospitalJean-Marc TROCELLO, MD, Principal investigator, Neurology, Lariboisière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980433
- Sponsor's protocol ID
- P121105
- Acronym
- WILSTIM
- Status last verified
- Jun 2021
- First submitted
- 24 Oct 2013
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT01980433
- Acronym / sponsor ID
- WILSTIM / P121105
- Keywords
- Wilson disease, Dystonia, Movement Disorders, Handwriting, Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Nov 2013 (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.
Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. The neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily life activities such as writing, which is particularly disabling, since writing is the only mean of communication in these patients with significant slurred speech. Treatment is limited and only partially effective.
Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown inhibiting properties when applied over the cortex. Since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right dystonic hand, assessed immediately at the end of the session.
Detailed description
This study investigates the handwriting performance of an homogeneous cohort of patients with Wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial magnetic stimulation (rTMS). Fifteen patients with focal right hand dystonia will receive randomly either active or sham rTMS (1 Hz) to the left somatosensory cortex (SSC) in one single 20 minutes session. Handwriting performance will be measured immediately after this unique session (Visual analogic scale of subjective discomfort in writing, DPRE and WCRS scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24 hours before the session. Three days later, the patient will receive the other session (sham rTMS or active rTMS) and the same parameters will be evaluated.
This is a single-center, randomized, crossover, prospective, clinical and double-blind study (the rTMS session is performed by the neurophysiologist, but the patient and the neurologist who will perform the handwriting evaluation are blind to the session).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Other: pre and post-rTMS electroencephalogram, Other: WCRS, Other: handwriting scale DPRE, Other: visual analog scale of discomfort writing and parameters collected on touchpadRepetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session. |
| Sham rTMS | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Other: pre and post-rTMS electroencephalogram, Other: WCRS, Other: handwriting scale DPRE, Other: visual analog scale of discomfort writing and parameters collected on touchpadPlacebo Transcranial Magnetic stimulation delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Wilson disease with focal right hand dystonia
- No modification of medical treatment for 6 months
- No botulinum toxin administration within the past four months
- Right handed
- Focal right hand dystonia
Key exclusion criteria (7 listed)
- Pregnant woman
- Guardianship procedure
- Seizure history
- Other cerebral lesions on cerebral MRI than met in Wilson Disease
- Unable to stay quiet for 30 minutes
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session. | Device | Active rTMS, Sham rTMS |
| pre and post-rTMS electroencephalogramto verify the absence of infraclinical seizures | Other | Active rTMS, Sham rTMS |
| WCRSWriter's cramp rating scale | Other | Active rTMS, Sham rTMS |
| handwriting scale DPREhandwriting in development and being evaluated by the NRC Wilson | Other | Active rTMS, Sham rTMS |
| visual analog scale of discomfort writing and parameters collected on touchpad | Other | Active rTMS, Sham rTMS |
Primary outcome
immediate and significant improvement in writing
Time frame: up to 1 week
Improvement of handwriting performance immediately after one single 20 minutes session of inhibitory (1 Hz) repetitive transcranial magnetic stimulation over the left somatosensory cortex. quantitative test score of writing WCRS Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
3 secondary outcomes
significant improvement in writing
Time frame: up to 1 week
improvement of dystonia on the scale WDRS
Time frame: up to 1 week
correlation between the scores and the other parameters of disease severity
Time frame: up to 1 week
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 15 Jun 2021.
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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.
Nathalie KUBIS, MD, PhD study director
Physiology Department, Lariboisière Hospital
Jean-Marc TROCELLO, MD principal investigator
Neurology, Lariboisière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), pre and post-rTMS electroencephalogram and WCRS in people with Wilson Disease and Movement Disorders, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 7 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 15 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
immediate and significant improvement in writing (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2021.