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

Spatial Neglect After Right Brain-damage Clinical Trial

— GVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834443
• Other study ID #: GVS-Therapy
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2013
• Last updated: April 15, 2013
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2013
• Source: Schoen Clinic Bad Aibling
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics committee of the Ludwig-Maximilians University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perceptual Disorders
• Spatial Neglect After Right Brain-damage

Intervention

Device:
• Direct current galvanic vestibular stimulation

Locations

Country	Name	City	State
Germany	Schoen Clinic Bad Aibling	Bad Aibling	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Schoen Clinic Bad Aibling	German Center for Vertigo and Balance Disorders (IFB)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in subjective visual vertical due to intervention	The visual vertical is assessed with the bucket test, in which subjects are asked to indicate when a visual line is vertical for them. 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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No