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

NCT02750371 | Completed

• 1 other identifier: CHUBX 2015/03
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cavernous Sinus Meningioma; Pituitary Adenoma

Keywords

Cavernous sinus meningioma; Pituitary adenoma; Hippocampus; Irradiation; Autobiographical memory

Outcome Measures

Primary Outcomes (1)

• Autobiographical memory test (TEMPau) score

  Two years after irradiation treatment end

Secondary Outcomes (4)

• Autobiographical memory test (TEMPau) score

  One year after irradiation treatment end

• Revised Self Consciousness Scale (RSCS) score

  One and two years after irradiation treatment end

• Quality of life questionnaire (QLQC-30/BN20) score

  One and two years after irradiation treatment end

• California Verbal Learning Test (CVLT) score

  One and two years after irradiation treatment end

Study Arms (1)

Patients with brain tumors treated by radiotherapy

EXPERIMENTAL

Patients with: \- meningioma of the cavernous sinus for which radiotherapy is planned Or \- a pituitary adenoma for which radiotherapy is planned

Other: Evaluation of autobiographical memory

Interventions

Evaluation of autobiographical memory OTHER

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

Patients with brain tumors treated by radiotherapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital Bordeaux

Bordeaux, 33076, France

Location

Related Publications (3)

• 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.

  PMID: 9142752 BACKGROUND

• 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.

  PMID: 17382578 BACKGROUND

• 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.

  PMID: 12874001 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Olivier BRANCHARD

  University Hospital, Bordeaux

  STUDY CHAIR

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: April 20, 2016
• First Posted: April 25, 2016
• Study Start: July 27, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)