Neurological assessment. Neurological assessment should be carried out on every person who experiences vertigo, dizziness, and/or problems with their balance but especially, in older adults and people with relevant history or suspected of central vestibular disorder including VM (Xxxxxx et al., 2004). The extent of the neurological assessment may depend on the subjective history (Xxxxxxx and Xxxxxxxx, 1996). The neurological assessment often includes cognitive function screening due to the close relationship between postural control, cognitive function, and aging in healthy adults (Xxxxx-Xxxxxxxxx et al., 2008; Xx-Xxxxx et al., 2011) and postural control, cognitive function, and vestibular disorders (Xxxxxxx and Xxxxxxx, 2015; Xxxx et al., 2017). It may also, include psychological assessment due to the close relationship between psychological symptoms, cognition, and vestibular symptoms (Xxxxxxx et al., 2013; Xxxxx and Xxxxxxxxxx, 2013).
Neurological assessment. Subject’s neurological status should be evaluated at screening to establish a baseline. After enrollment, subjects should be evaluated for any neurological symptoms at each of the timepoints specified in the SOA. During the hospitalization period, evaluations of neurological status may need to be increased. Changes in neurological status should be reported as an adverse event per Section 9.
Neurological assessment. Neurological assessments will be standardized by using the Mini-Mental State Examination (MMSE) standard version 2.0. The MMSE is a 5 to 10 minute, 11-question measure that examines various areas of cognitive function: orientation, attention, immediate recall, short-term recall, language, and the ability to follow simple verbal and written commands. The MMSE is divided into 2 sections. The first part requires vocal responses to the examiner's questions. In the second part of the exam, the subject is asked to follow verbal and written instructions, write a sentence spontaneously, and copy a geometric figure. A full neurological assessment will be completed during screening to establish a baseline. For subjects enrolled in Cohort 1, subsequent post-baseline assessments will be performed before anti-CD19 CAR T cells administration on Day 0, Day 1, Day 3, Day 5, Day 7, and every other day while hospitalized, as well as on Day 28 and Month 3. For subjects enrolled in Cohort 2, a subsequent post-baseline assessment will be performed on Day 28. If the assessment shows neurologic function has not returned to baseline (± 3 points) on Day 28, then the MMSE will continue to be performed at Month 3 and every 3 months until the results have returned to baseline (± 3 points) or until Month 24. Every attempt should be made to dedicate a single research staff member familiar with or trained in the administration of the MMSE to conduct the assessment to minimize inter-rater variability. If CNS symptoms persist, continue to perform the MMSE every 2 days until resolution of symptoms or discharged from the hospital.
