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

Not Applicable

• Conditions: Spatial Neglect After Right Brain-damage
• Interventions: Device: Direct current galvanic vestibular stimulation

• Registration Number: NCT01834443
• Lead Sponsor: Schoen Clinic Bad Aibling

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Status Verified: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-15
• Last Update Submitted: 2013-04-15
• Study First Posted: 2013-04-17
• Last Update Posted: 2013-04-17
• Primary Completion: 2014-01
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GVS CL	Direct current galvanic vestibular stimulation	Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid
GVS CR	Direct current galvanic vestibular stimulation	Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid
GVS Sham	Direct current galvanic vestibular stimulation	Transmastoid galvanic stimulation set-up is applied, with only 30s of stimulation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in visual-tactile search task due to intervention	Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)	Subjects searches objects glued to a board, the time needed to do so is measured
Change in subjective haptic vertical due to intervention	Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)	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.

Trial Locations

Locations (1)

Schoen Clinic Bad Aibling; 🇩🇪 Bad Aibling, Bavaria, Germany