Non-invasive brain stimulation improves neglect and functional outcome after stroke

Neglect measured using the Catherine Bergego Scale (CBS) was chosen as a primary outcome measure since the ecological validity in a rehabilitation facility is high (Azouvi, 2016). It quantifies the influence of spatial neglect-related deficits in the ADL. The CBS consists of 10 items, such as grooming, etc. Items are scored on a 0-to-3 scale, with 0 indicating no neglect and 3 indicating severe neglect (range, 0–30). The CBS was completed by nurses, who were blinded to the protocol, observing a patient performing different ADL. Primary and secondary outcomes are all measured at admission to and discharge from inpatient neurorehabilitation (mean length of stay 50 days). The primary outcome (neglect) is additionally measured 3 months after discharge from inpatient neurorehabilitation, to analyse whether post-stroke time and length of stay is a predictive factor for the positive cTBS effects.

Measured at admission to and discharge from inpatient neurorehabilitation (mean length of stay 50 days):
1. Body representational neglect tested by means of the Fluff Test (Cocchini et al. 2001). Hereby, twenty-four sticky notes (12 left, 12 right) are attached to the participant's body (trunk and thighs) and have to be removed with one’s eyes closed. In the present study, the performance was measured by the total number of removed sticky notes on the left side of the body.
2. Free visual exploration measured by the Two Part Picture Tests in the near and far space. The Two Part Picture Test is a commonly used detector for screening of visuospatial neglect (Brunila et al., 2003). In this assessment two simultaneously presented pictures have to be described. In both pictures a room is shown containing 10 items each (10 items in the left picture and 10 in the right picture). Correctly named items were scored one point each. Asymmetry-Score was calculated using the number of correct items on the left divided by the total number of correct items ( Asymmetry Score= ((correct items left)/(correct items total)); Brunila et al., 2003). The test was conducted twice: once in the near space and once in the far space. For the near space the pictures were shown in reading distance on an A3 landscape format paper. Hereby, the test was placed on the table centrally to the patient's midsagittal axis. For the far space the same pictures were presented on a 685 cm x 1215 cm flat screen (LED) monitor at a distance of two meters.
3. Visual search behaviour assessed by the bird cancellation task (Hopfner et al. 2015). 64 targets (birds displayed as flying straight to the participant) and 96 distractors (birds displayed as flying in other direction) were shown on a 685 cm x 1215 cm touch screen (Hopfner et al. 2015). The patient was seated comfortably in 0.5 meter distance to the screen. Targets had to be identified by tapping them with an arm extension consisting of a stick with a rubber tip. The center of mass of the spatial distribution of correct identified targets was used to calculate the Center of Cancellation (CoC) (Rorden & Karnath, 2010). Since the inter-individual as well as an intra-individual variability in neglect tests is high (Lundervold et al., 2005) and a battery is more sensitive than any single test alone (Azouvi et al., 2002) a composite score was derived from these neglect tests. Consequently, the patient’s individual performance for each test was calculated between admission and discharge of hospital. The mean out of these four test performances was calculated resulting in an individual composite score.
4. General functional outcome measured by the Functional Independent Measurement (FIM) which is a standardized assessment for ADL, including 18 items rated on a 7-point scale: 1 = total assistance; 2 = maximal assistance; 3 = moderate assistance; 4 = minimal contact assistance; 5 = supervision or set-up; 6 = modified independence; and 7 = complete independence (Keith et al. 1987). The FIM consists of 13 motor (or physical) items and 5 cognitive items. The scores range from 13 to 91 for the motor subscale and from 5 to 35 for the cognitive subscale.
5. Functional outcome assessed using the Lucerne ICF based Multidisciplinary Observation Scale (LIMOS). The reason why LIMOS was included as an additional measure was that it’s has been shown to be more responsive than FIM (Vanbellingen et al. 2016). The LIMOS include 7 chapters incorporating 45 domains: 1) Learning and applying knowledge, 2) General tasks and demands, 3) Communication, 4) Mobility, 5) Self-care, 6) Domestic life and 7) Interpersonal interactions and relationships (for more details see Ottiger et al. 2015, Vanbellingen et al. 2016). Every item is rated on a 5-point scale (1 -5), so that total scores can range from 45 to 225. The 5-point scale for the LIMOS is defined as follows: 1 = patient is not able to fulfil a task or need assistance up to 75 % (corresponding to “complete”); 2 = patient is able to fulfil tasks with assistance of 25 % to 75 % (corresponding to “severe”); 3 = patient is able to fulfil tasks with assistance less than 25 % or under supervision (corresponding to “moderate”); 4 = patient is able to fulfil tasks independently but needs more time and/or with auxiliary materials, aids (corresponding to “slight”); 5 = patient is able to fulfil tasks independently (corresponding to “none”). A major advantage of the LIMOS is that upper limb in ADL is assessed. Consequently, we were able to validate a modified upper limb LIMOS score, LIMOS upper limb, which consists of 5 items, i.e.: lifting up and carrying objects, fine hand use, hand and arm use, washing the upper body, putting on and taking off clothes in the upper body. Score ranges from 5 (totally dependent) to 25 (independent).