Isolated Cervical DystoniaIRMF-DIFFNCT02877836
Functional MRI and DTI in the Preoperative Assessment of Dystonia
A study testing magnetic resonance imaging (fMRI) in people with Isolated Cervical Dystonia and Complex Dystonia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Isolated Cervical Dystonia, Complex Dystonia, Spasticity
- What is being tested?
- magnetic resonance imaging (fMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2014to 3 Jun 2016
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age limits ≥ 18 et < 85 years
- Right-handed patients/healthy controls, according to Edinburgh Handedness Inventory
- The participating subjects must be affiliated to the French public health system
- Written consent to participate in this study
- For the patients
- Patients affected by isolated or complex dystonia admitted to hospital in the Unit of Functional Neurosurgery in order to assess eligibility for deep cerebral stimulation therapy
Show all 11Show fewer
- Ability to understand the instructions to perform the experimental paradigm (the motor task) used in the design of the functional MRI
- For the healthy control subjects :
- Absence of current neurologic pathology
- Absence of personal history of neurologic pathology, including perinatal anoxic injury, meningitis, vascular, metabolic, inflammatory pathology, epilepsy, cranial trauma with loss of consciousness or with associated neurological symptoms.
- Absence of orthopaedic injury in the upper limbs
Who cannot join
- Non Specific criteria
- Contraindication for the realization of a MRI (pacemaker, valve prothesis non compatible with MRI, cochlear implant, aneuvrysmal clip, presence of an Intra-ocular metallic foreign object or coronary endoprosthesis)
- Pregnancy, breastfeeding
- Adults protected by the law
- Non Specific criteria • Severe dyskinesia preventing the realization of motor task during functional MRI without general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Magnetic Resonance and Diffusion Tensor Imaging in the Preoperative Assessment of Dystonia
The aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. The efficiency of this technique depends on the relative preservation of the function and the structure of the motor network .
The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this study might contribute to expand our understanding of the abnormalities in motor circuit activation and the integrity of CNS structure underlying dystonia. This study might contribute therefore to the refinement of Deep brain stimulation indications and techniques in complex dystonia syndromes
Read the detailed description
Advances in the field of functional neurosurgery, neuroradiology and virus neuronal tracing studies have expanded our knowledge of the circuits underlying the clinical expression of several neurologic syndromes. Globus pallidus internus (GPi) Deep brain stimulation (DBS) is a validated technique for the treatment of 'isolated dystonia'. The efficiency of this therapy in 'complex dystonia', commonly associated with focal brain lesions, is limited and heterogeneous. Broadening indications for DBS therapy to complex DDS disorders require further improvement of preoperative assessment of motor circuit functional reorganization and white matter integrity. The efficacy of neuromodulation in these clinical syndromes is determined by the severity of pyramidal involvement, the interactions between cortico-striato-pallido-thalamic and cerebello-thalamo-cortical circuits and motor network reorganization at the cortical level.
The aim of the study is to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns in a group of dystonic patients in comparison to healthy controls (HC). Further analysis will assess the recruitment pattern in different patient subgroups defined according to clinical and radiological criteria relevant to GPi DBS eligibility (hyperkinetic/ hypokinetic and prepallidal/ postpallidal). Diffusion tensor imaging (DTI) will be applied to the assessment of the topographic distribution and severity of white matter lesions in the group of dystonic patients in comparison with HC.
Further knowledge concerning motor network organization and white matter integrity after focal brain lesions might contribute to the understanding of this mitigated response to DBS and to the refinement of DBS indications and techniques in secondary dystonia
- Conditions
- Isolated Cervical Dystonia, Complex Dystonia, Spasticity
- Being tested
- magnetic resonance imaging (fMRI)
- Keywords
- Dystonia, fMRI, DTI, DBS
- Medical subject headings
- Muscle Spasticity, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (fMRI)Other
To identify movement-related fMRI activation pattern in dystonic patients in comparison to healthy controls Assessment of white matter integrity in the corticospinal tract in a group og dystonic patients compared with the healthy control group
| Study group | Role | What they receive |
|---|---|---|
| Segmentary dystonia | Other | to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns Receives: Other: magnetic resonance imaging (fMRI) |
| Hemidystonia | Other | to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns Receives: Other: magnetic resonance imaging (fMRI) |
| Generalized dystonia | Other | to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns Receives: Other: magnetic resonance imaging (fMRI) |
| Healthy control subjects | Other | to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns Receives: Other: magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrity of Motor circuit reorganization in dystonia
All the subjects participating in the study will undergo a Functional MRI study with a 'box and block' design comparing brain activity during the execution of a motor task and rest. Resting state fMRI will also be recorded. Statistical Parametric Mapping (SPM8) software will be used in order to perform spatially extended statistical processes to test the hypothesis whether there is a difference between both groups in functional imaging data. This analysis will provide a statistical map showing the clusters of brain activation where there is a significant difference between the group of dystonic patients and the group of healthy controls
Measured: 1 day
Integrity of corticospinal tract white matter in dystonia
Fractional anisotropy (FA) is a measure derived of Diffusion tensor imaging that quantifies the degree of directionality of the local tract structure. This parameter is considered to be a marker for white matter tract integrity.
FSL software will be used to analyse Diffusion Tensor Imaging (DTI) data
- Tract-based spatial statistics (TBSS) will be used to obtain a voxelwise statistical map comparing fractional anisotropy in the major tracts in the group ot dystonic patients and the group of healthy controls.
- Probabilistic tractography will be used to obtain tract-derived DTI parameters in the corticospinal and thalamocortical tracts that will be correlated with clinical scales (Burke-Fahn-Marsden Dystonia scale). Several DTI parameters will be analysed: mean fractional anisotropy, mean diffusivity, parallel and perpendicular diffusivity
Measured: 1 day
Secondary outcomes (1)
Movement-related fMRI activation pattern in dystonic patients
To identify movement-related fMRI activation pattern in different subgroups of dystonic patients classified following clinical (hyperkinetic versus hypokinetic) and radiologic criteria (prepallidal versus postpallidal lesions) Statistical Parametric Mapping (SPM8) software will be used to test the hypothesis whether patients with different clinical phenotypes (hyperkinetic versus hypokinetic) or patients with different radiologic presentation (prepallidal versus postpallidal lesions) show significant differences in the pattern of brain activation related to the execution of a motor task.
This analysis will provide a statistical map showing the clusters of brain activation where there is a significant difference between both groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start19 Sep 2014
- Primary completion3 Jun 2016
- Study completion3 Jun 2016
Why it stopped: end of inclusion period and difficulties on recruitment of one patient group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Gonzalez, MD PhD, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877836
- Sponsor's protocol ID
- 9095
- Acronym
- IRMF-DIFF
- Status last verified
- Dec 2021
- First submitted
- 6 Jul 2016
- Last updated
- 28 Dec 2021
- 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 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance and Diffusion Tensor Imaging in the Preoperative Assessment of Dystonia
- ClinicalTrials.gov ID
- NCT02877836
- Acronym / sponsor ID
- IRMF-DIFF / 9095
- Conditions
- Isolated Cervical Dystonia, Complex Dystonia, Spasticity
- Keywords
- Dystonia, fMRI, DTI, DBS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of inclusion period and difficulties on recruitment of one patient group
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 3 Jun 2016 (actual)
- First posted
- 24 Aug 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 aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. The efficiency of this technique depends on the relative preservation of the function and the structure of the motor network .
The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this study might contribute to expand our understanding of the abnormalities in motor circuit activation and the integrity of CNS structure underlying dystonia. This study might contribute therefore to the refinement of Deep brain stimulation indications and techniques in complex dystonia syndromes
Detailed description
Advances in the field of functional neurosurgery, neuroradiology and virus neuronal tracing studies have expanded our knowledge of the circuits underlying the clinical expression of several neurologic syndromes. Globus pallidus internus (GPi) Deep brain stimulation (DBS) is a validated technique for the treatment of 'isolated dystonia'. The efficiency of this therapy in 'complex dystonia', commonly associated with focal brain lesions, is limited and heterogeneous. Broadening indications for DBS therapy to complex DDS disorders require further improvement of preoperative assessment of motor circuit functional reorganization and white matter integrity. The efficacy of neuromodulation in these clinical syndromes is determined by the severity of pyramidal involvement, the interactions between cortico-striato-pallido-thalamic and cerebello-thalamo-cortical circuits and motor network reorganization at the cortical level.
The aim of the study is to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns in a group of dystonic patients in comparison to healthy controls (HC). Further analysis will assess the recruitment pattern in different patient subgroups defined according to clinical and radiological criteria relevant to GPi DBS eligibility (hyperkinetic/ hypokinetic and prepallidal/ postpallidal). Diffusion tensor imaging (DTI) will be applied to the assessment of the topographic distribution and severity of white matter lesions in the group of dystonic patients in comparison with HC.
Further knowledge concerning motor network organization and white matter integrity after focal brain lesions might contribute to the understanding of this mitigated response to DBS and to the refinement of DBS indications and techniques in secondary dystonia
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Segmentary dystonia | Other | Other: magnetic resonance imaging (fMRI)to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns |
| Hemidystonia | Other | Other: magnetic resonance imaging (fMRI)to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns |
| Generalized dystonia | Other | Other: magnetic resonance imaging (fMRI)to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns |
| Healthy control subjects | Other | Other: magnetic resonance imaging (fMRI)to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age limits ≥ 18 et < 85 years
- Right-handed patients/healthy controls, according to Edinburgh Handedness Inventory
- The participating subjects must be affiliated to the French public health system
- Written consent to participate in this study
- For the patients
Key exclusion criteria (5 listed)
- Non Specific criteria
- Non Specific criteria • Severe dyskinesia preventing the realization of motor task during functional MRI without general anesthesia
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 |
|---|---|---|
| magnetic resonance imaging (fMRI)To identify movement-related fMRI activation pattern in dystonic patients in comparison to healthy controls Assessment of white matter integrity in the corticospinal tract in a group og dystonic patients compared with the healthy control group | Other | Generalized dystonia, Healthy control subjects, Hemidystonia, Segmentary dystonia |
Primary outcome
Integrity of Motor circuit reorganization in dystonia
Time frame: 1 day
All the subjects participating in the study will undergo a Functional MRI study with a 'box and block' design comparing brain activity during the execution of a motor task and rest. Resting state fMRI will also be recorded. Statistical Parametric Mapping (SPM8) software will be used in order to perform spatially extended statistical processes to test the hypothesis whether there is a difference between both groups in functional imaging data. This analysis will provide a statistical map showing the clusters of brain activation where there is a significant difference between the group of dystonic patients and the group of healthy controls
Integrity of corticospinal tract white matter in dystonia
Time frame: 1 day
Fractional anisotropy (FA) is a measure derived of Diffusion tensor imaging that quantifies the degree of directionality of the local tract structure. This parameter is considered to be a marker for white matter tract integrity. FSL software will be used to analyse Diffusion Tensor Imaging (DTI) data 1. Tract-based spatial statistics (TBSS) will be used to obtain a voxelwise statistical map comparing fractional anisotropy in the major tracts in the group ot dystonic patients and the group of healthy controls. 2. Probabilistic tractography will be used to obtain tract-derived DTI parameters in the corticospinal and thalamocortical tracts that will be correlated with clinical scales (Burke-Fahn-Marsden Dystonia scale). Several DTI parameters will be analysed: mean fractional anisotropy, mean diffusivity, parallel and perpendicular diffusivity
1 secondary outcome
Movement-related fMRI activation pattern in dystonic patients
Time frame: 1 day
Results and safety
The study was stopped early (reason given: end of inclusion period and difficulties on recruitment of one patient group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- 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.
Victoria Gonzalez, MD PhD principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging (fMRI) in people with Isolated Cervical Dystonia and Complex Dystonia, run by University Hospital, Montpellier 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 5 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: stopped early, as of the sponsor's last update on 28 Dec 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. 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 was stopped early (reason given: end of inclusion period and difficulties on recruitment of one patient group). Results are not available in the source record.
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?
Integrity of Motor circuit reorganization in dystonia (time frame: 1 day). The study lists 2 primary outcomes in all. 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 28 Dec 2021.