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CompletedNCT03739008Updated Aug 12, 2019

Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia

An observational study in Transient Global Amnesia and Reversible Vasoconstriction Syndrome, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
3
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Transient Global Amnesia
  • Reversible Vasoconstriction Syndrome

Keywords

  • Thunderclap headache
03

In context

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's enrollment of 3 is below the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.

Browse Headache Disorders, Primary studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a proven or probable RCVS concomitant with certain transient global amnesia

Exclusion criteria

Exclusion Criteria:

  • Not proven transient global amnesia, not proven or possible RCVS
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
3 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Occurrence of concomitant TGA and proven RCVS

    Occurrence of concomitant transient global amnesia (TGA) and proven Reversible cerebral vasoconstriction syndrome (RCVS)

    Time frame: 1 day

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2012 to primary completion in Nov 2018, 82 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2018
First posted
Nov 13, 2018
StartActual
Jan 1, 2012
Primary completionActual
Nov 8, 2018
CompletionActual
Nov 8, 2018
Last update
Aug 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03739008
Responsible party
Sponsor
First posted
Nov 13, 2018
Start date
Jan 1, 2012
Primary completion
Nov 8, 2018
Completion
Nov 8, 2018
Last update
Aug 12, 2019

Study contacts

Nicolas Gaillard, MD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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