Progressive Supranuclear PalsyGait-PSPNCT04096651
Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy
A study testing gait recordings, brain magnetic resonance imaging and oculomotor movement recordings in people with Progressive Supranuclear Palsy, run by Centre Hospitalier Universitaire de la Guadeloupe.
Trial summary
The main hypothesis is that the gait and postural deficits in the Caribbean form of PSP may be associated with a dysfunction of the cerebral cortex, as they result from sub-cortical involvement in classical forms. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- gait recordings, brain magnetic resonance imaging and oculomotor movement recordings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2015to 12 Jul 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient :
- Patients who met the clinical criteria for PSP and Gd-PSP
- Walking and standing alone without assistance
- Patient or responsible third party who received information about the study and who signed the informed consent
- French
- Patients over 40 years
Show all 12Show fewer
- Clinically detectable eye movement anomaly
- Witnesses :
- To be affiliated or beneficiary of social security scheme
- French person
- Major subjects, matched for age (± 3 years) and sex, showing no neurological or psychiatric disease or severe progressive disease
- No Indication against MRI
Who cannot join
- Patient :
- Patient not affiliated with the social security system
- Cognitive impairment: MMSE ≤ 20; FAB ≤ 12
- psychiatric disorders likely to interfere with exploration; severe postural disorders
- MRI not feasible Witnesses
- Not affiliated or benificiary of social security scheme
- Not a french person
- Somebody showing neurological or psychiatric disease or severe progressive disease
About this study
The main hypothesis is that the gait and postural deficits in the Caribbean form of PSP may be associated with a dysfunction of the cerebral cortex, as they result from sub-cortical involvement in classical forms. The investigators will characterize the gait and posture with a force platform to collect biomechanical gait parameters, coupled with the kinematic and electromyographic (EMG) study. Then the investigators realize a multimodal imaging study [structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI)] that allow us to determine if a correlation can be found between the clinical characteristics of postural control and walking on one hand, and morphological changes and structural MRI changes in cortico-subcortical pathways on the other hand. The study of performance on neuropsychological tests, registration of ocular movements and the analysis of functional cortical activity will complete our multimodal approach. A better understanding of these disorders is expected to propose new drug treatment and rehabilitative strategies.
Read the detailed description
Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease (6/100 000 inhabitants) characterized by the association of Parkinson's syndrome, a paralysis of the verticality of the gaze and an alteration early balance and walking with the onset of falls during the first year of evolution of the disease. From a neuropathological point of view, it is characterized by a tauopathy with neurodegeneration within the basal ganglia, cerebellum, and midbrain (which includes the mesencephalic locomotor region-MLR).
In the Caribs this pathology is abnormally frequent (incidence over 3 times higher than expected), and represents 1/3 of the total Parkinsonian syndromes. In these patients, cortical pathology predominates leading to different cognitive deficit relative to patients with the classical form of PSP. Conversely, in PSP patients, imaging data suggest a preferential midbrain-thalamocortical pathway dysfunction. Pathophysiological mechanisms causing gait disturbances and postural control presented by these patients remains however not fully elucidated . In patients with Caribbean PSP, of which the clinical features are specific, gait disorders and falls appear later in the course of the disease (2.5 years on average) suggesting perhaps a different physiopathological mechanism. Consequently weak knowledge of the mechanisms involved, none specific treatment is currently available and the taking in therapeutic charge of these disorders rests essentially on a re-educative approach that remains poorly codified.
In this study, gait and balance disorders will be recorded using a force platform, coupled with kinematic study and EMG in patients with classical form of PSP and Caribbean one, and in controls. The functional and anatomy of brain will be examined using a multimodal brain imaging approach (with DTI. Performance in neuropsychological tests and oculomotor movements will also be measured. A comparative and correlation analyses will be performed to assess the link between gait, balance, oculomotor and cognitive performances and brain anatomy, and the differences between subjects groups. Caribbean PSP patients are recruited from Neurology and Physical Medicine and Rehabilitation of University Hospital of Pointe-à-Pitre and Fort de France, Classical PSP patients are be recruited from the Centre d'Investigation Clinique (CIC) of the Pitié-Salpêtrière hospital, and healthy volunteers from both centers.
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- gait recordings, brain magnetic resonance imaging, oculomotor movement recordings
- Keywords
- progressive supranuclear palsy PSP, atypical parkinsonism, gait disorders, neurophysiology, imaging
- Medical subject headings
- Supranuclear Palsy, Progressive, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait recordingsOther
gait recordings
brain magnetic resonance imagingOther
brain magnetic resonance imaging
oculomotor movement recordingsOther
oculomotor movement recordings
| Study group | Role | What they receive |
|---|---|---|
| PSP Classic | Other | 15 patients with a "classical" form of PSP are recruited to realize all the tests of the multimodal approach. Receives: Other: gait recordings; Other: brain magnetic resonance imaging; Other: oculomotor movement recordings |
| Caribbean PSP | Other | 15 patients with a "Caribbean PSP" are recruited to realize all the tests of the multimodal approach. Receives: Other: gait recordings; Other: brain magnetic resonance imaging; Other: oculomotor movement recordings |
| Healthy controls | Other | 15 persons with no PSP are recruited to realize all the tests of the multimodal approach. Receives: Other: gait recordings; Other: brain magnetic resonance imaging; Other: oculomotor movement recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait velocity
gait recordings
Measured: at inclusion
Secondary outcomes (2)
brain anatomy
magnetic resonance imaging
Measured: at inclusion
oculomotor movements recordings
oculomotor movements recordings
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start28 Sep 2015
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center of Martinique, Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
- Investigators
- Annie LANNUZEL, PU-PH, Study director, University Hospital of GuadeloupeRégine EDRAGAS, PH, Principal investigator, University Hospital of MartiniqueMarie-Laure WELTER, PU-PH, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096651
- Sponsor's protocol ID
- RBM-PAP-2015/19
- Acronym
- Gait-PSP
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT04096651
- Acronym / sponsor ID
- Gait-PSP / RBM-PAP-2015/19
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- progressive supranuclear palsy PSP, atypical parkinsonism, gait disorders, neurophysiology, imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- University Hospital Center of Martinique, Groupe Hospitalier Pitie-Salpetriere
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 20 Sep 2019 (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.
The main hypothesis is that the gait and postural deficits in the Caribbean form of PSP may be associated with a dysfunction of the cerebral cortex, as they result from sub-cortical involvement in classical forms. The investigators will characterize the gait and posture with a force platform to collect biomechanical gait parameters, coupled with the kinematic and electromyographic (EMG) study. Then the investigators realize a multimodal imaging study [structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI)] that allow us to determine if a correlation can be found between the clinical characteristics of postural control and walking on one hand, and morphological changes and structural MRI changes in cortico-subcortical pathways on the other hand. The study of performance on neuropsychological tests, registration of ocular movements and the analysis of functional cortical activity will complete our multimodal approach. A better understanding of these disorders is expected to propose new drug treatment and rehabilitative strategies.
Detailed description
Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease (6/100 000 inhabitants) characterized by the association of Parkinson's syndrome, a paralysis of the verticality of the gaze and an alteration early balance and walking with the onset of falls during the first year of evolution of the disease. From a neuropathological point of view, it is characterized by a tauopathy with neurodegeneration within the basal ganglia, cerebellum, and midbrain (which includes the mesencephalic locomotor region-MLR).
In the Caribs this pathology is abnormally frequent (incidence over 3 times higher than expected), and represents 1/3 of the total Parkinsonian syndromes. In these patients, cortical pathology predominates leading to different cognitive deficit relative to patients with the classical form of PSP. Conversely, in PSP patients, imaging data suggest a preferential midbrain-thalamocortical pathway dysfunction. Pathophysiological mechanisms causing gait disturbances and postural control presented by these patients remains however not fully elucidated . In patients with Caribbean PSP, of which the clinical features are specific, gait disorders and falls appear later in the course of the disease (2.5 years on average) suggesting perhaps a different physiopathological mechanism. Consequently weak knowledge of the mechanisms involved, none specific treatment is currently available and the taking in therapeutic charge of these disorders rests essentially on a re-educative approach that remains poorly codified.
In this study, gait and balance disorders will be recorded using a force platform, coupled with kinematic study and EMG in patients with classical form of PSP and Caribbean one, and in controls. The functional and anatomy of brain will be examined using a multimodal brain imaging approach (with DTI. Performance in neuropsychological tests and oculomotor movements will also be measured. A comparative and correlation analyses will be performed to assess the link between gait, balance, oculomotor and cognitive performances and brain anatomy, and the differences between subjects groups. Caribbean PSP patients are recruited from Neurology and Physical Medicine and Rehabilitation of University Hospital of Pointe-à-Pitre and Fort de France, Classical PSP patients are be recruited from the Centre d'Investigation Clinique (CIC) of the Pitié-Salpêtrière hospital, and healthy volunteers from both centers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSP Classic | Other | Other: gait recordings, Other: brain magnetic resonance imaging, Other: oculomotor movement recordings15 patients with a "classical" form of PSP are recruited to realize all the tests of the multimodal approach. |
| Caribbean PSP | Other | Other: gait recordings, Other: brain magnetic resonance imaging, Other: oculomotor movement recordings15 patients with a "Caribbean PSP" are recruited to realize all the tests of the multimodal approach. |
| Healthy controls | Other | Other: gait recordings, Other: brain magnetic resonance imaging, Other: oculomotor movement recordings15 persons with no PSP are recruited to realize all the tests of the multimodal approach. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient :
- Patients who met the clinical criteria for PSP and Gd-PSP
- Walking and standing alone without assistance
- Patient or responsible third party who received information about the study and who signed the informed consent
- French
Key exclusion criteria (8 listed)
- Patient not affiliated with the social security system
- Cognitive impairment: MMSE ≤ 20; FAB ≤ 12
- psychiatric disorders likely to interfere with exploration; severe postural disorders
- MRI not feasible Witnesses
- Not affiliated or benificiary of social security scheme
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 |
|---|---|---|
| gait recordingsgait recordings | Other | Caribbean PSP, Healthy controls, PSP Classic |
| brain magnetic resonance imagingbrain magnetic resonance imaging | Other | Caribbean PSP, Healthy controls, PSP Classic |
| oculomotor movement recordingsoculomotor movement recordings | Other | Caribbean PSP, Healthy controls, PSP Classic |
Primary outcome
gait velocity
Time frame: at inclusion
gait recordings
2 secondary outcomes
brain anatomy
Time frame: at inclusion
oculomotor movements recordings
Time frame: at inclusion
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 20 Sep 2019.
- 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.
Annie LANNUZEL, PU-PH study director
University Hospital of Guadeloupe
Régine EDRAGAS, PH principal investigator
University Hospital of Martinique
Marie-Laure WELTER, PU-PH principal investigator
Groupe Hospitalier Pitie-Salpetriere
Questions about this trial
What is this clinical trial studying?
A study testing gait recordings, brain magnetic resonance imaging and oculomotor movement recordings in people with Progressive Supranuclear Palsy, run by Centre Hospitalier Universitaire de la Guadeloupe.
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 12 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
gait velocity (time frame: at inclusion). 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 20 Sep 2019.