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

cTBS reduces disability by ameliorating neglect – a randomized, sham controlled and double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25274476
Enrollment
30
Registered
2018-05-14
Start date
2014-04-01
Completion date
Unknown
Last updated
2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right hemisphere stroke patients with neglect Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

All patients received, besides neurorehabilitation, a 4-week standardized training protocol which included a daily smooth pursuit training, which is a specific effective neglect training (Hopfner et a

Sponsors

Swiss National Science Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Sixty patients (aged between 27 - 86 years, mean = 66.4, SD = 14.2; 24 women) with a first, right-hemispheric stroke (RHS) participated in this study: 1. Thirty neglect patients entered the randomisation procedure 2. Thirty patients without neglect served as a control group

Exclusion criteria

Exclusion criteria: 1. Patients suffering from major psychiatric diseases and other comorbidities (drug and alcohol abuse) 2. For the patients participating in the TMS study a history of epilepsy and metallic implants were further exclusion criteria (Rossi et al. 2009)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026