The study involves the recruitment of patients prior to brain surgery. While an fMRI is performed, half of the volunteers will be randomly assigned to perform a language listening task, and half will be assigned to perform a language generation task. Brain function maps will be used by surgeons to identify language areas for surgical planning. The study is designed to determine if using a language generation task for surgical planning results in higher scores on post-surgery language measures as compared to using a language listening task.
Note: Compare with dysesthesia. After much discussion, it has been agreed to recommend that paresthesia be used to describe an abnormal sensation that is not unpleasant while dysesthesia be used preferentially for an abnormal sensation that is considered to be unpleasant. The use of one term ( paresthesia ) to indicate spontaneous sensations and the other to refer to evoked sensations is not favored. There is a sense in which, since paresthesia refers to abnormal sensations in general, it might include dysesthesia, but the reverse is not true. Dysesthesia does not include all abnormal sensations, but only those that are unpleasant.
This document describes the definitions for protocol registration data elements submitted to for interventional studies (clinical trials) and observational studies. These definitions are mostly adapted from
42 CFR Part 11 .
Data element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials .
Note : The term "clinical study" is used to refer to both interventional and observational studies. The term "participant" is used to refer to human subjects.
* Required * § Required if Study Start Date is on or after January 18, 2017 [*] Conditionally required
1. Study Identification