Skip to main content
OpenTrials
Completed

NCT Number: NCT02750371

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cavernous Sinus Meningioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Adenoma Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bordeaux

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of autobiographical memory

Other

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

Primary outcomes

  1. Autobiographical memory test (TEMPau) score

    Time frame: Two years after irradiation treatment end

Secondary outcomes

  1. Autobiographical memory test (TEMPau) score

    Time frame: One year after irradiation treatment end

  2. Revised Self Consciousness Scale (RSCS) score

    Time frame: One and two years after irradiation treatment end

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

    Time frame: One and two years after irradiation treatment end

  4. California Verbal Learning Test (CVLT) score

    Time frame: One and two years after irradiation treatment end

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ISOMAB

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2016
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.