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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Pituitary Adenoma
Cavernous Sinus Meningioma

Treatments

Other: Evaluation of autobiographical memory

Study type

Interventional

Funder types

Other

Identifiers

NCT02750371
CHUBX 2015/03

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Patients with brain tumors treated by radiotherapy
Experimental group
Description:
Patients with: - meningioma of the cavernous sinus for which radiotherapy is planned Or - a pituitary adenoma for which radiotherapy is planned
Treatment:
Other: Evaluation of autobiographical memory

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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