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

Not Applicable

Completed

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

• Registration Number: ISRCTN25274476
• Lead Sponsor: Swiss National Science Foundation

Brief Summary

2019 results in: https://doi.org/10.1093/brain/awz029 (added 15/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-02-01
• Study Start: 2018-05-14
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eglect 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.