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Hippocampal Radiation Exposure and Memory

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00603694
First received: January 16, 2008
Last updated: January 9, 2009
Last verified: January 2008
  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

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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by University Health Network, Toronto:
Hippocampus
Memory
Radiation

Additional relevant MeSH terms:
Trigeminal Neuralgia
Arteriovenous Malformations
Congenital Abnormalities
Hemangioma
Cardiovascular Abnormalities
Cardiovascular Diseases
Cranial Nerve Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Nervous System Diseases
Trigeminal Nerve Diseases
Vascular Diseases
Vascular Malformations

ClinicalTrials.gov processed this record on November 20, 2014