Transient Global AmnesiaNCT03739008
Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia
An observational study of Transient Global Amnesia and Reversible Vasoconstriction Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Global Amnesia, Reversible Vasoconstriction Syndrome
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 8 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a proven or probable RCVS concomittant with certain transient global amnesia in the Neurology department of Gui de Chauliac and Lariboisière hospitals
Who may be able to join
- Patients with a proven or probable RCVS concomitant with certain transient global amnesia
Who cannot join
- Not proven transient global amnesia, not proven or possible RCVS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia : a Serie of 3 Cases Report
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks.
This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.
- Keywords
- Thunderclap headache
- Medical subject headings
- Amnesia, Transient Global, Headache Disorders, Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of concomitant TGA and proven RCVS
Occurrence of concomitant transient global amnesia (TGA) and proven Reversible cerebral vasoconstriction syndrome (RCVS)
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 posted13 Nov 2018
- Study start1 Jan 2012
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Global AmnesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Gaillard, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739008
- Sponsor's protocol ID
- RECHMPL18_0423
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia : a Serie of 3 Cases Report
- ClinicalTrials.gov ID
- NCT03739008
- Acronym / sponsor ID
- RECHMPL18_0423
- Keywords
- Thunderclap headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 13 Nov 2018 (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.
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks.
This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a proven or probable RCVS concomittant with certain transient global amnesia in the Neurology department of Gui de Chauliac and Lariboisière hospitals
Key inclusion criteria (1 listed)
- Patients with a proven or probable RCVS concomitant with certain transient global amnesia
Key exclusion criteria (1 listed)
- Not proven transient global amnesia, not proven or possible RCVS
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
Occurrence of concomitant TGA and proven RCVS
Time frame: 1 day
Occurrence of concomitant transient global amnesia (TGA) and proven Reversible cerebral vasoconstriction syndrome (RCVS)
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 12 Aug 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Nicolas Gaillard, MD principal investigator
University Hospital, Montpellier
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 Transient Global Amnesia and Reversible Vasoconstriction Syndrome, 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 1 inclusion and 1 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 12 Aug 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?
Occurrence of concomitant TGA and proven RCVS (time frame: 1 day). 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 12 Aug 2019.