Hippocampal Radiation Exposure and Memory

NCT00603694 | Completed DMC

• 1 other identifier: 07-0023-CE
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arteriovenous Malformation; Schwannoma; Trigeminal Neuralgia

Keywords

Hippocampus; Memory; Radiation

Study Arms (3)

1

(Experimental group): Receiving \> 2 Gy SRS to left hippocampus (n=10)

2

(Low-dose control group): Receiving \< 0.5 Gy SRS to left hippocampus (n=10)

3

(High-dose control group): Receiving whole brain PCI (n=10)

Eligibility Criteria

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

Study Population

Patients who have consented to GK radiosurgery or cranial radiation.

You may qualify if:

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

You may not qualify if:

• 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
• 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 & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Arteriovenous Malformations; Neurilemmoma; Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

CA (1)