Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect

Study Overview
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Brief Summary
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The purpose of this study is to determine whether galvanic vestibular stimulation is effective in the treatment of spatial neglect after right brain-damage.

Official Title
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Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect

Conditions
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Spatial Neglect After Right Brain-damage

Intervention / Treatment
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* Device: Direct current galvanic vestibular stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: spatial neglect after unilateral ischemic infarction or unilateral haemorrhage Exclusion Criteria: Chronic epilepsy Metallic implants (including pacemakers) Brain tumors Scalp inflammation Degenerative disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GVS CL<br>Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid | Device: Direct current galvanic vestibular stimulation<br> <br> * Other names: Serial-no 0028;|
| Experimental: GVS CR<br>Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid | Device: Direct current galvanic vestibular stimulation<br> <br> * Other names: Serial-no 0028;|
| Sham Comparator: GVS Sham<br>Transmastoid galvanic stimulation set-up is applied, with only 30s of stimulation | Device: Direct current galvanic vestibular stimulation<br> <br> * Other names: Serial-no 0028;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neglect Test (NET)due to intervention, the German version of the Behavioral Inattention Test (BIT) |  | Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual-tactile search task due to intervention | Subjects searches objects glued to a board, the time needed to do so is measured | Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing) | 
| Change in subjective haptic vertical due to intervention | The haptic vertical is assessed with a wooden device, where subjects are asked to adjust a rod into a vertical position. Deviations (in degrees) are measured. | Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spatial neglect, galvanic vestibular stimulation as therapy