NCT03739008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
Last Updated

August 12, 2019

Status Verified

November 1, 2018

Enrollment Period

6.9 years

First QC Date

November 9, 2018

Last Update Submit

August 8, 2019

Conditions

Keywords

Thunderclap headache

Outcome Measures

Primary Outcomes (1)

  • Occurrence of concomitant TGA and proven RCVS

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

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Amnesia, Transient GlobalHeadache Disorders, Primary

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmnesiaMemory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersHeadache Disorders

Study Officials

  • Nicolas Gaillard, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 13, 2018

Study Start

January 1, 2012

Primary Completion

November 8, 2018

Study Completion

November 8, 2018

Last Updated

August 12, 2019

Record last verified: 2018-11

Locations