the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years. This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
58
neurosurgery
neurosurgery
Thermoformed mask
Assistance Publique Hôpitaux de Marseille
Marseille, France
Evaluation of pain during the hospitalization (3 days)
Questionary (numeric pain intensity scale)
Time frame: 12 months
Evaluation of tumor control at 3 months
No increase of volume greater than 50% on the MRI
Time frame: 12 months
Evaluation of tumor control at 6 months
No increase of volume greater than 50% on the MRI
Time frame: 12 months
Occurrence of clinical side effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
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