Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory

NCT ID: NCT02750371

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-27
• Study Completion Date: 2022-03-31

Brief Summary

Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.

However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.

Detailed Description

Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory.

Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma.

Investigators hope for confirm our results from pilot study.

Conditions

Cavernous Sinus Meningioma; Pituitary Adenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with brain tumors treated by radiotherapy

Patients with:

• meningioma of the cavernous sinus for which radiotherapy is planned

Or

• a pituitary adenoma for which radiotherapy is planned

Group Type: EXPERIMENTAL

Evaluation of autobiographical memory

Intervention Type: OTHER

Patients will answer several questionnaires one and two years after irradiation treatment end.

Interventions

Evaluation of autobiographical memory

Patients will answer several questionnaires one and two years after irradiation treatment end.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 35 and 65.
• Patient with:

• meningioma of the cavernous sinus for which radiotherapy is planned
• or a pituitary adenoma for which radiotherapy is planned
• French Mother tongue
• Person affiliated to national insurance
• Person who give its verbal agreement to participate

Exclusion Criteria

• Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.).
• Treatment with chemotherapy
• General intellectual abilities deficient (IQ <80)
• Extension front of their meningioma
• Deficient Language Skills.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier BRANCHARD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

University Hospital Bordeaux

Bordeaux, , France

Countries

France

References

Nadel L, Moscovitch M. Memory consolidation, retrograde amnesia and the hippocampal complex. Curr Opin Neurobiol. 1997 Apr;7(2):217-27. doi: 10.1016/s0959-4388(97)80010-4.

Reference Type: BACKGROUND

PMID: 9142752 (View on PubMed)

Cabeza R, St Jacques P. Functional neuroimaging of autobiographical memory. Trends Cogn Sci. 2007 May;11(5):219-27. doi: 10.1016/j.tics.2007.02.005. Epub 2007 Mar 26.

Reference Type: BACKGROUND

PMID: 17382578 (View on PubMed)

Mizumatsu S, Monje ML, Morhardt DR, Rola R, Palmer TD, Fike JR. Extreme sensitivity of adult neurogenesis to low doses of X-irradiation. Cancer Res. 2003 Jul 15;63(14):4021-7.

Reference Type: BACKGROUND

PMID: 12874001 (View on PubMed)

Other Identifiers

CHUBX 2015/03

Identifier Type: -

Identifier Source: org_study_id