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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

January 16, 2008
January 9, 2009
September 2007
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Complete list of historical versions of study NCT00603694 on ClinicalTrials.gov Archive Site
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Hippocampal Radiation Exposure and Memory
Hippocampal Radiation Exposure and Memory: A Pilot Study

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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients who have consented to GK radiosurgery or cranial radiation.

  • Arteriovenous Malformation
  • Schwannoma
  • Trigeminal Neuralgia
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  • 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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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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
Both
18 Years and older
No
Contact: Heather Sharpe, B.Sc. 416-603-5445 heather.sharpe@rmp.uhn.on.ca
Canada
 
NCT00603694
07-0023-CE
Yes
Dr. Cynthia Menard, University Health Network
University Health Network, Toronto
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University Health Network, Toronto
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP