Neurology DepartmentNCT05388552
Abnormal Hyperkinetic Movements Post Acute Stroke
An observational study of Neurology Department, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
The occurrence of abnormal movements is a frequent reason for consultation in neurology. The etiologies are broadly separated into "primary causes", intrinsically neurological diseases (of genetic or degenerative origin), and "secondary causes". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurology Department
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with abnormal hyperkinetic movements post-stroke, managed in the neurovascular intensive care unit
Who may be able to join
- Adult patients (age 18 years old)
- Patients with a stroke treated in the neurovascular intensive care unit of the Delafontaine Hospital in Saint-Denis (Hospitalization within 48 hours of the onset of the neurovascular episode
- Patients with abnormal hyperkinetic movements
Who cannot join
- Opposition of the patient or his entourage to participation in the registry
- Abnormal myoclonic movements of an epileptic nature
- Minor patients
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital DELAFONTAINE
Saint-Denis, Île-de-France Region, 93200
Stéphanie Cossec, 0142356140 ext. 6962, coordination.rechercheclinique@ghtpdfr.fr
Guillaume BAILLE, MD PH
About this study
Official title: Clinical Features of Hyperkinetic Involuntary Movements Controlateral to Hemiplegia in Acute Stroke
The occurrence of abnormal movements is a frequent reason for consultation in neurology. The etiologies are broadly separated into "primary causes", intrinsically neurological diseases (of genetic or degenerative origin), and "secondary causes". In addition to certain medications or toxic substances, brain damage can be a cause. In this register, 22% of involuntary abnormal movements are related to a stroke and 1 to 4% of strokes are complicated by abnormal movements.
These are manifested by a parkinsonian syndrome or conversely by hypercinesia which can take the form of chorea or ballisms. Most hyperkinetic movements occur in the acute phase of the neurovascular event.
The frequency of these abnormal movements is still uncertain and their semeiological description has been the subject of only rare publications. It seems relevant to be interested in the frequency of these neurological phenomena and has their semeiologic characteristic
Read the detailed description
The occurrence of abnormal movements is a frequent reason for consultation in neurology. The etiologies are broadly separated into "primary causes", in example intrinsically neurological diseases (of genetic or degenerative origin), and "secondary causes". In addition to certain medications or toxic substances, brain damage can be a cause. In this register, 22% of involuntary abnormal movements are related to a stroke and 1 to 4% of strokes are complicated by abnormal movements.
These are manifested by a parkinsonian syndrome or conversely by hypercinesia which can take the form of chorea or ballisms. Most hyperkinetic movements occur in the acute phase of the neurovascular event. . The pathophysiology seems simple and explained by a direct lesion or hypoperfusion of structures involved in the loops of the basal ganglia, especially when the putamen is affected. Intuitively, these abnormal hyperkinetic movements affect the contralateral hemibody to the vascular lesion, or the ipsilateral rating to the sensory and/ or motor deficit. However, observations have already been reported of involuntary hyperkinetic abnormal movements of the contralateral side to that presenting hemiplegia, i.e. in theorie controlled by a cerebral hemisphere free of acute cerebral lesion.
The frequency of these abnormal movements is still uncertain and their semeiological description has been the subject of only rare publications. A largest cohort reports abnormal involuntary movements very heterogeneous as to their clinical presentation (rotation of the head, orpharyngeal stereotypies to the limbs, compulsive manipulations of the environment or repeated passive mobilization of the contralateral limb paralyzed) In addition, the correlation of this type of neurological manifestations with vascular lesions has not yet been elucidated.
However, the unusual nature of this type of movement, it seems relevant to be interested in the frequency of these neurological phenomena and has their semeiologic characteristic.
- Conditions
- Neurology Department
- Keywords
- hyperkinetic movements, acute stroke
- Medical subject headings
- Hyperkinesis, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of abnormal contralateral movements to hemiplegia in the acute phase of a stroke
incidence of abnormal contralateral movements to hemiplegia in the acute phase of a stroke
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start23 May 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurology DepartmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388552
- Sponsor's protocol ID
- CHSD_0018_NEURO
- Other IDs
- 2021-A03230-41
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mehanna R, Jankovic J. Movement disorders in cerebrovascular disease. Lancet Neurol. 2013 Jun;12(6):597-608. doi: 10.1016/S1474-4422(13)70057-7. Epub 2013 Apr 19.
PubMed 23602779Defebvre L, Krystkowiak P. Movement disorders and stroke. Rev Neurol (Paris). 2016 Aug-Sep;172(8-9):483-487. doi: 10.1016/j.neurol.2016.07.006. Epub 2016 Jul 28.
PubMed 27476417Vercueil L, Andriantseheno ML, Umeda Y, Carre S, Sellal F. Hyperkinesia contralateral to acute hemiplegia: relevance of previous frontal lesions. Parkinsonism Relat Disord. 2000 Apr 1;6(2):107-110. doi: 10.1016/s1353-8020(99)00059-0.
PubMed 10699392Ghika J, Bogousslavsky J, van Melle G, Regli F. Hyperkinetic motor behaviors contralateral to hemiplegia in acute stroke. Eur Neurol. 1995;35(1):27-32. doi: 10.1159/000117085.
PubMed 7737242
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features of Hyperkinetic Involuntary Movements Controlateral to Hemiplegia in Acute Stroke
- ClinicalTrials.gov ID
- NCT05388552
- Acronym / sponsor ID
- CHSD_0018_NEURO
- Conditions
- Neurology Department
- Keywords
- hyperkinetic movements, acute stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 May 2022 (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 occurrence of abnormal movements is a frequent reason for consultation in neurology. The etiologies are broadly separated into "primary causes", intrinsically neurological diseases (of genetic or degenerative origin), and "secondary causes". In addition to certain medications or toxic substances, brain damage can be a cause. In this register, 22% of involuntary abnormal movements are related to a stroke and 1 to 4% of strokes are complicated by abnormal movements.
These are manifested by a parkinsonian syndrome or conversely by hypercinesia which can take the form of chorea or ballisms. Most hyperkinetic movements occur in the acute phase of the neurovascular event.
The frequency of these abnormal movements is still uncertain and their semeiological description has been the subject of only rare publications. It seems relevant to be interested in the frequency of these neurological phenomena and has their semeiologic characteristic
Detailed description
The occurrence of abnormal movements is a frequent reason for consultation in neurology. The etiologies are broadly separated into "primary causes", in example intrinsically neurological diseases (of genetic or degenerative origin), and "secondary causes". In addition to certain medications or toxic substances, brain damage can be a cause. In this register, 22% of involuntary abnormal movements are related to a stroke and 1 to 4% of strokes are complicated by abnormal movements.
These are manifested by a parkinsonian syndrome or conversely by hypercinesia which can take the form of chorea or ballisms. Most hyperkinetic movements occur in the acute phase of the neurovascular event. . The pathophysiology seems simple and explained by a direct lesion or hypoperfusion of structures involved in the loops of the basal ganglia, especially when the putamen is affected. Intuitively, these abnormal hyperkinetic movements affect the contralateral hemibody to the vascular lesion, or the ipsilateral rating to the sensory and/ or motor deficit. However, observations have already been reported of involuntary hyperkinetic abnormal movements of the contralateral side to that presenting hemiplegia, i.e. in theorie controlled by a cerebral hemisphere free of acute cerebral lesion.
The frequency of these abnormal movements is still uncertain and their semeiological description has been the subject of only rare publications. A largest cohort reports abnormal involuntary movements very heterogeneous as to their clinical presentation (rotation of the head, orpharyngeal stereotypies to the limbs, compulsive manipulations of the environment or repeated passive mobilization of the contralateral limb paralyzed) In addition, the correlation of this type of neurological manifestations with vascular lesions has not yet been elucidated.
However, the unusual nature of this type of movement, it seems relevant to be interested in the frequency of these neurological phenomena and has their semeiologic characteristic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with abnormal hyperkinetic movements post-stroke, managed in the neurovascular intensive care unit
Key inclusion criteria (3 listed)
- Adult patients (age 18 years old)
- Patients with a stroke treated in the neurovascular intensive care unit of the Delafontaine Hospital in Saint-Denis (Hospitalization within 48 hours of the onset of the neurovascular episode
- Patients with abnormal hyperkinetic movements
Key exclusion criteria (3 listed)
- Opposition of the patient or his entourage to participation in the registry
- Abnormal myoclonic movements of an epileptic nature
- Minor patients
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
incidence of abnormal contralateral movements to hemiplegia in the acute phase of a stroke
Time frame: Day 1
incidence of abnormal contralateral movements to hemiplegia in the acute phase of a stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Results publication: PubMed 23602779Mehanna R, Jankovic J. Movement disorders in cerebrovascular disease. Lancet Neurol. 2013 Jun;12(6):597-608. doi: 10.1016/S1474-4422(13)70057-7. Epub 2013 Apr 19.
- Results publication: PubMed 27476417Defebvre L, Krystkowiak P. Movement disorders and stroke. Rev Neurol (Paris). 2016 Aug-Sep;172(8-9):483-487. doi: 10.1016/j.neurol.2016.07.006. Epub 2016 Jul 28.
- Results publication: PubMed 10699392Vercueil L, Andriantseheno ML, Umeda Y, Carre S, Sellal F. Hyperkinesia contralateral to acute hemiplegia: relevance of previous frontal lesions. Parkinsonism Relat Disord. 2000 Apr 1;6(2):107-110. doi: 10.1016/s1353-8020(99)00059-0.
- Results publication: PubMed 7737242Ghika J, Bogousslavsky J, van Melle G, Regli F. Hyperkinetic motor behaviors contralateral to hemiplegia in acute stroke. Eur Neurol. 1995;35(1):27-32. doi: 10.1159/000117085.
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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.
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 Neurology Department, run by Centre Hospitalier de Saint-Denis 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume BAILLE, MD, PhD (01 42 35 62 97, guillaume.baille@ch-stdenis.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of abnormal contralateral movements to hemiplegia in the acute phase of a stroke (time frame: Day 1). 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 NCT05388552, which also lists 4 linked publications.
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 25 May 2022.