NCT02866812

Brief Summary

During the last decade, the embolization has become the treatment of choice for ruptured intracranial aneurysms, to improve the neurological outcome of patients. At the same time, for his safety, she also became the technique allowing prophylactic treatment of unruptured intracranial aneurysms discovered incidentally during imaging exams. Regarding patients with ruptured intracranial aneurysms, patients who survive often have a reduced quality of life while one in two has a good neurological outcome after embolization. Depression, anxiety and fatigue, whose the psycho-social impact is important, are often cited. This description has often been done without considering the realized type of treatment (surgery or embolization) and mostly of neurological and functional status of the patient remotely (disability or not in daily activities). Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and embolization is programmed. They would present an cognitive impairment in one case in five at 1 month of treatment. If depression, fatigue and difficult return to working life are logically found in patients with severe sequelae (disability in daily activities) of their ruptured intracranial aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms. A precise status of these populations is necessary, especially as the discovery and treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that their good neurological status should allow "a priori" to return easily at the active life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

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

March 17, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2021

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

4.9 years

First QC Date

August 10, 2016

Last Update Submit

December 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • depression

    Depression evaluated using the Hamilton scale

    6 months

Secondary Outcomes (2)

  • tired

    6 months

  • anxiety

    6 months

Study Arms (1)

patient with endovascular treatment for intracranial aneurysm

EXPERIMENTAL
Other: questionnaires assessing the state of fatigue, depression and anxiety

Interventions

patient with endovascular treatment for intracranial aneurysm

Eligibility Criteria

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

You may qualify if:

  • patient with endovascular treatment for intracranial aneurysm (ruptured or unruptured)
  • patient older than 18 years
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program

You may not qualify if:

  • patient with anterior treatment for intracranial aneurysm
  • bipolar disorder, schizophrenia or schizoaffective disorder diagnostic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 15, 2016

Study Start

March 17, 2016

Primary Completion

February 17, 2021

Study Completion

September 17, 2021

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations