Cervical DystoniaSTAC2NCT02834871
Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia
A study testing Electromyogram in people with Cervical Dystonia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Electromyogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements
- having signed a consent for study participation
- No Inclusion Criteria:
- Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...)
- Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months
- Ongoing neuroleptic treatment
Show all 11Show fewer
- Pregnancy or breastfeeding
- Lack of insurance coverage
- For patients, are added the following no inclusion criteria are added:
- Trembling cervical dystonia
- Injection of botulinum toxin in the past three months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.
- Conditions
- Cervical Dystonia
- Being tested
- Electromyogram
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyogramDevice
| Study group | Role | What they receive |
|---|---|---|
| patients with cervical dystonia | Other | Computerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia Receives: Device: Electromyogram |
| patients without cervical dystonia | Other | Computerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia Receives: Device: Electromyogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
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 Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834871
- Sponsor's protocol ID
- SSA_2014_23
- Acronym
- STAC2
- Status last verified
- Mar 2017
- First submitted
- 13 Jul 2016
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Carment L, Maier MA, Sangla S, Guiraud V, Mesure S, Vidailhet M, Lindberg PG, Bleton JP. Does dystonic muscle activity affect sense of effort in cervical dystonia? PLoS One. 2017 Feb 13;12(2):e0172019. doi: 10.1371/journal.pone.0172019. eCollection 2017.
PubMed 28192488
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT02834871
- Acronym / sponsor ID
- STAC2 / SSA_2014_23
- Conditions
- Cervical Dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jul 2016 (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.
The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with cervical dystonia | Other | Device: ElectromyogramComputerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia |
| patients without cervical dystonia | Other | Device: ElectromyogramComputerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements
- having signed a consent for study participation
- Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...)
- Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months
- Ongoing neuroleptic treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Electromyogram | Device | patients with cervical dystonia, patients without cervical dystonia |
Primary outcome
Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition
Time frame: two hours
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 28 Mar 2017.
- Results publication: PubMed 28192488Carment L, Maier MA, Sangla S, Guiraud V, Mesure S, Vidailhet M, Lindberg PG, Bleton JP. Does dystonic muscle activity affect sense of effort in cervical dystonia? PLoS One. 2017 Feb 13;12(2):e0172019. doi: 10.1371/journal.pone.0172019. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyogram in people with Cervical Dystonia, run by Fondation Ophtalmologique Adolphe de Rothschild 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 0 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 28 Mar 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?
Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition (time frame: two hours). 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 NCT02834871, 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 28 Mar 2017.