Hippocampal Radiation Exposure and Memory - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00603694

Purpose

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.

Condition
Arteriovenous Malformation Schwannoma Trigeminal Neuralgia

MedlinePlus related topics: Arteriovenous Malformations Memory Trigeminal Neuralgia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Hippocampal Radiation Exposure and Memory: A Pilot Study

Further study details as provided by University Health Network, Toronto:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	September 2007

Groups/Cohorts
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients who have consented to GK radiosurgery or cranial radiation.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603694

Contacts

Contact: Heather Sharpe, B.Sc.

416-603-5445

heather.sharpe@rmp.uhn.on.ca

Locations

Canada, Ontario
Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital	Recruiting
Toronto, Ontario, Canada, M5T 2S8
Principal Investigator: Cynthia Menard, Docorate
Sub-Investigator: Iwa Kong

Sponsors and Collaborators

University Health Network, Toronto

More Information

Responsible Party:	University Health Network ( Dr. Cynthia Menard )
Study ID Numbers:	07-0023-CE
Study First Received:	January 16, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00603694
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Hippocampus
Memory
Radiation

Study placed in the following topic categories:

Neuralgia
Aneurysm
Cardiovascular Abnormalities
Trigeminal neuralgia
Vascular Diseases
Neurilemmoma
Pain
Neuroendocrine Tumors
Neuroectodermal Tumors
Signs and Symptoms
Neuromuscular Diseases
Neoplasms, Germ Cell and Embryonal

Peripheral Nervous System Diseases
Vascular Malformations
Hemangioma
Neuroepithelioma
Neurologic Manifestations
Arteriovenous Malformations
Peripheral Nervous System Neoplasms
Congenital Abnormalities
Neuroma
Nervous System Neoplasms
Nerve Sheath Neoplasms
Trigeminal Neuralgia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nervous System Diseases

Neoplasms, Vascular Tissue
Trigeminal Nerve Diseases
Cardiovascular Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on January 14, 2009