Hippocampal Radiation Exposure and Memory

Trigeminal Neuralgia Clinical Trial

Official title:

Hippocampal Radiation Exposure and Memory: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603694
• Other study ID #: 07-0023-CE
• Status: Completed
• Phase: N/A
• First received: January 16, 2008
• Last updated: June 21, 2016
• Start date: September 2007
• Est. completion date: December 2013

Study information

• Verified date: June 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriovenous Malformation
• Arteriovenous Malformations
• Hemangioma
• Schwannoma
• Trigeminal Neuralgia

Locations

Country	Name	City	State
Canada	Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada,