Dystonia, PrimaryLICIdystonieNCT03381456
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
A study testing LICI in people with Dystonia, Primary, run by University Hospital, Lille at 1 site in France.
Trial summary
Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Primary
- What is being tested?
- LICI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Apr 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with hand dystonia : writers cramp
- Subject affiliated to social security regimen.
- For healthy volunteers :
- Healthy volunteer without neurological disorders based on sensorimotor examination.
- Subject affiliated to social security regimen.
Who cannot join
- Subject unable to receive informed consent (dementia).
- Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant).
- Patient using a psychotrope treatment.
- Patient under guardianship or curatorship.
- Pregnant or nursing women.
- Patient with a cardiac stimulator.
- For healthy volunteers only :
- Abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)
Trial locations and contacts
1 site in 1 country.
About this study
Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.
- Conditions
- Dystonia, Primary
- Being tested
- LICI
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LICIOther
Paired pulse TMS to measure LICI and late cortical disinhibition
| Study group | Role | What they receive |
|---|---|---|
| Healthy subject | Experimental | LICI Receives: Other: LICI |
| Dystonic subject | Experimental | LICI Receives: Other: LICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-interval intracortical inhibition (LICI) level
Amount of inhibition at interstimulus intervals of between 50 to 300ms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study startApr 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonia, PrimaryStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 10 patient with dystonia and 10 healthy subject paired by sex and age.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Derambure, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381456
- Sponsor's protocol ID
- 2013_51
- Other IDs
- 2014-A00244-43
- Acronym
- LICIdystonie
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
- ClinicalTrials.gov ID
- NCT03381456
- Acronym / sponsor ID
- LICIdystonie / 2013_51
- Conditions
- Dystonia, Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Dec 2017 (actual)
- 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.
Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 patient with dystonia and 10 healthy subject paired by sex and age.
| Arm | Type | Receives |
|---|---|---|
| Healthy subject | Experimental | Other: LICILICI |
| Dystonic subject | Experimental | Other: LICILICI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with hand dystonia : writers cramp
- Subject affiliated to social security regimen.
- Healthy volunteer without neurological disorders based on sensorimotor examination.
- Subject affiliated to social security regimen.
Key exclusion criteria (8 listed)
- Subject unable to receive informed consent (dementia).
- Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant).
- Patient using a psychotrope treatment.
- Patient under guardianship or curatorship.
- Pregnant or nursing women.
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 |
|---|---|---|
| LICIPaired pulse TMS to measure LICI and late cortical disinhibition | Other | Dystonic subject, Healthy subject |
Primary outcome
long-interval intracortical inhibition (LICI) level
Time frame: Baseline
Amount of inhibition at interstimulus intervals of between 50 to 300ms
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 22 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Philippe Derambure, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LICI in people with Dystonia, Primary, run by University Hospital, Lille 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 5 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 22 Dec 2017. 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?
long-interval intracortical inhibition (LICI) level (time frame: Baseline). 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 22 Dec 2017.