Hippocampal Radiation Exposure and Memory

Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.

In this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.

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Key information

Conditions

Arteriovenous Malformation Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neuroma Schwannoma Stomatognathic Diseases Trigeminal Nerve Diseases Trigeminal Neuralgia Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients planned for radiosurgery for benign disorders (Groups 1&2).
Patients planned for prophylactic cranial irradiation (Group 3)

Exclusion criteria

Previous cranial radiation
Severe psychiatric disorder
Severe cognitive or memory impairment (MMSE < 21)
Non-English speaking, which will potentially make memory testing difficult and unreliable.
Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures
Patients on steroid medications.
Left hand dominant patients
Dose exposure to left hippocampus >0.5Gy and <2Gy. We will attempt to estimate dose to hippocampus prior to enrollment using pre-planning on diagnostic imaging to minimize exclusion of patients due to dose exposure >0.5 Gy and < 2Gy following baseline memory testing.
Benzodiazepine or narcotics given on the day of radiotherapy/radiosurgery prior to completion of the study procedures
Previous brain surgery within one year prior to radiosurgery
Pregnant women

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Hippocampal Radiation Exposure and Memory: A Pilot Study

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2013
First posted: Jan 29, 2008
Registry last updated: Jun 23, 2016

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.

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

Completed