Cervical Dystonia, PrimarySTICOBNCT02894359
Computer Modelling of the Cervical Spine Movements in Cervical Dystonia
An observational study of Cervical Dystonia, Primary, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary neck muscle activity causing abnormal head postures and movements. It is the most frequent form of adult focal dystonia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia, Primary
- What is being tested?
- cone beam imagery of cervical spine
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2016to 25 Oct 2018
- Phase
- Observational
- 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
Study population: 10 CD patients without Botulinum neurotoxin injection in the preceding 3 months and 10 control subjects, age and gender matched. All subjetcts included in the study will undergo cervical spine imagery with the cone beam device (static and cervical rotation).
Who may be able to join
- Tonic form of focal or segmental cervical dystonia (diagnostic confirmed by a neurologist specialized in movement disorders) for CD patients, or absence of CD for control subjects
- absence of treatment by botulinum neurotoxin, or last injection > 3 months
- age > 18 and < 71 years
- informed consent
- medical insurance coverage
Who cannot join
- CD mobile (clonic) and/or head tremor
- patient unable to sit without moving the head during the examination (x-ray pictures with cone beam)
- Other neurological disease with effect on the posture and/or movement of the cervical region
- Pain or traumatism of the cervical region requiring medical or surgical treatment in the preceding 6 months
- Pregnant or breast feeding patient
- Participation in another research with a potential impact on evaluation criteria
- patient under judiciary protection
Trial locations and contacts
1 site in 1 country.
About this study
Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary neck muscle activity causing abnormal head postures and movements. It is the most frequent form of adult focal dystonia. The distribution of dystonic muscles is unique for each patient, explaining the variety of patterns encountered.
The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin injections and/or specific retraining therapy programmes. Therefore, analyzing the characteristics of abnormal head movements and identifying the dystonic muscles are the key points of these treatments.
To a better understanding of the posture and movement disorders of head and neck, we wish to establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy subjects built from images obtained with the "Cone Beam " system. Then we will compare the cervical posture and movements for each of ten CD patients matched in age and genre to the computer model. Comparison with patients' images in the axial plane reconstructed by computer with the 3-D computer model will lead to the description of various patterns of CD. Analysis of the musculoskeletal disturbances in CD should be a help to improve the localization of Botulinum Neurotoxin injection sites as well as retraining programmes.
- Conditions
- Cervical Dystonia, Primary
- Being tested
- cone beam imagery of cervical spine
- Keywords
- Cervical spine, Musculoskeletal imagery, computer modelling of cervical spine, ConeBeam.
- Medical subject headings
- Cervical Dystonia, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone beam imagery of cervical spineDevice
| Study group | Role | What they receive |
|---|---|---|
| CD patients | 10 patients with a cervical dystonia Receives: Device: cone beam imagery of cervical spine | |
| control subjects | 10 healthy patients Receives: Device: cone beam imagery of cervical spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of bone marks positions (degrees) in patients ans control motions
positions measured in degrees with computerized imaging
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start27 Oct 2016
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Dystonia, PrimaryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre BLETON, PhD, Study chair, Fondation OPH A de RothschildSophie SANGLA, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894359
- Sponsor's protocol ID
- SSA_2016_19
- Acronym
- STICOB
- Status last verified
- Jan 2019
- First submitted
- 5 Sep 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Modelling of the Cervical Spine Movements in Cervical Dystonia
- ClinicalTrials.gov ID
- NCT02894359
- Acronym / sponsor ID
- STICOB / SSA_2016_19
- Conditions
- Cervical Dystonia, Primary
- Keywords
- Cervical spine, Musculoskeletal imagery, computer modelling of cervical spine, ConeBeam.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 9 Sep 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.
Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary neck muscle activity causing abnormal head postures and movements. It is the most frequent form of adult focal dystonia. The distribution of dystonic muscles is unique for each patient, explaining the variety of patterns encountered.
The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin injections and/or specific retraining therapy programmes. Therefore, analyzing the characteristics of abnormal head movements and identifying the dystonic muscles are the key points of these treatments.
To a better understanding of the posture and movement disorders of head and neck, we wish to establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy subjects built from images obtained with the "Cone Beam " system. Then we will compare the cervical posture and movements for each of ten CD patients matched in age and genre to the computer model. Comparison with patients' images in the axial plane reconstructed by computer with the 3-D computer model will lead to the description of various patterns of CD. Analysis of the musculoskeletal disturbances in CD should be a help to improve the localization of Botulinum Neurotoxin injection sites as well as retraining programmes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD patients | – | Device: cone beam imagery of cervical spine10 patients with a cervical dystonia |
| control subjects | – | Device: cone beam imagery of cervical spine10 healthy patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 CD patients without Botulinum neurotoxin injection in the preceding 3 months and 10 control subjects, age and gender matched. All subjetcts included in the study will undergo cervical spine imagery with the cone beam device (static and cervical rotation).
Key inclusion criteria (5 listed)
- Tonic form of focal or segmental cervical dystonia (diagnostic confirmed by a neurologist specialized in movement disorders) for CD patients, or absence of CD for control subjects
- absence of treatment by botulinum neurotoxin, or last injection > 3 months
- age > 18 and < 71 years
- informed consent
- medical insurance coverage
Key exclusion criteria (7 listed)
- CD mobile (clonic) and/or head tremor
- patient unable to sit without moving the head during the examination (x-ray pictures with cone beam)
- Other neurological disease with effect on the posture and/or movement of the cervical region
- Pain or traumatism of the cervical region requiring medical or surgical treatment in the preceding 6 months
- Pregnant or breast feeding patient
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 |
|---|---|---|
| cone beam imagery of cervical spine | Device | CD patients, control subjects |
Primary outcome
comparison of bone marks positions (degrees) in patients ans control motions
Time frame: baseline
positions measured in degrees with computerized imaging
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 24 Jan 2019.
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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.
Jean-Pierre BLETON, PhD study chair
Fondation OPH A de Rothschild
Sophie SANGLA, MD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia, Primary, 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 5 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 24 Jan 2019. 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 bone marks positions (degrees) in patients ans control motions (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 24 Jan 2019.