A clinical study of non-invasive brain stimulation in unilateral spatial neglect after stroke

Not Applicable

• Conditions: Stroke, hemiplegia; perception disorders; unilateral spatial neglect

• Registration Number: RBR-78jvzx
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-03
• Study Completion: 2020-04-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients will eligible for inclusion in the trial if they will aged at least 18 years and had USN after ischemic stroke diagnosis within six months of the start of stroke symptoms (subacute phase). Ischemic stroke will be confirm using computed tomography (CT) or magnetic resonance imaging (MRI), and USN will objectively diagnosed using conventional Behavior Inattention Tasks (BIT-C) with a cutoff value of <129.

Exclusion Criteria

Individuals will excluded if they will suffer hemorrhagic stroke, metal-in-cranium injuries near the electrode placement area, intracerebral vascular clips or any other electrically sensitive support system, clinical instability, epilepsy, severe cognitive impairment, bilateral lesions, global aphasia, previous visual disturbances, pregnancy, or other neurological diseases.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease the degree of unilateral spatial neglect after treatment verified by Behavior Inattention Test (BIT), from finding a variation of at least 15% in the pre and post intervention measurements

Secondary Outcome Measures

Name	Time	Method
Decrease the degree of unilateral spatial neglect after treatment verified by Catherine Bergego scale, from finding a variation of at least 15% in the pre and post intervention measurements;Increasing the degree of autonomy observed with the Barthel indez, from the finding of a change of at least 15% in pre and post intervention measurements.;Increasing the degree of quality of life observed with the European (5D) Quality of life Scale, from the finding of a change of at least 15% in pre and post intervention measurements.;Decrease of stroke severity observed with the National Institutes of Health Stroke Scale (NIHSS), from the finding of a change of at least 15% in pre and post intervention measurements.;Increasing the degree of functional impairment observed with the Functional Independence Measure (FIM), from the finding of a change of at least 15% in pre and post intervention measurements.