Cervical DystoniaSTAC1NCT02069548
Analysis of Three-dimensional Movements of the Head in Cervical Dystonia
An observational study of Cervical Dystonia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Dystonia
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Apr 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis) and without botulinum toxin injections during the last 6 previous months before baseline. Patients will be selected consecutively among the outpatients with movement disorder of 3 study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital (Paris) Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD subjects. They will be selected in Sainte-Anne Hospital (Paris)
Who may be able to join
- Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders
Who cannot join
- Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
- Neuroleptic treatment in course
- Pregnancy
- breast feeding
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Analysis of 3-D Movements of the Head in Cervical Dystonia: Comparative Assessment of the Cervical Mobility With the Mean of 3D Sensors Motion Capture Between Patients With Cervical Dystonia and Control Subjects
This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.
- Conditions
- Cervical Dystonia
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical dystonia | Not described | |
| matched controlled subjects | matched in age (+/- 5 years) and gender |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes, measured in patients and matched control subjects
Measured: baseline
Secondary outcomes (3)
movements disorders in cervical dystonia
correlations between the movements disorders (range of motion, angular velocity, direction deviation) and the clinical characteristics of cervical dystonia, among patients with cervical dystonia
Measured: baseline
head posture
influence of vision on the head posture
Measured: baseline
range of motion
influence of vision on the range of motion
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sangla Sophie, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069548
- Sponsor's protocol ID
- 2013-A01400-45
- Acronym
- STAC1
- Status last verified
- Jun 2015
- First submitted
- 18 Feb 2014
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of 3-D Movements of the Head in Cervical Dystonia: Comparative Assessment of the Cervical Mobility With the Mean of 3D Sensors Motion Capture Between Patients With Cervical Dystonia and Control Subjects
- ClinicalTrials.gov ID
- NCT02069548
- Acronym / sponsor ID
- STAC1 / 2013-A01400-45
- Conditions
- Cervical Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Feb 2014 (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.
This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical dystonia | – | – |
| matched controlled subjects | – | –matched in age (+/- 5 years) and gender |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis) and without botulinum toxin injections during the last 6 previous months before baseline. Patients will be selected consecutively among the outpatients with movement disorder of 3 study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital (Paris) Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD subjects. They will be selected in Sainte-Anne Hospital (Paris)
Key inclusion criteria (1 listed)
- Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders
Key exclusion criteria (4 listed)
- Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
- Neuroleptic treatment in course
- Pregnancy
- breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes
Time frame: baseline
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes, measured in patients and matched control subjects
3 secondary outcomes
movements disorders in cervical dystonia
Time frame: baseline
head posture
Time frame: baseline
range of motion
Time frame: baseline
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 Oct 2016.
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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.
Sangla Sophie, MD principal investigator
Fondation Ophtalmologique Adolphe 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, 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 1 inclusion and 4 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 Oct 2016. 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?
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes (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 Oct 2016.