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

April 15, 2013 updated by: Schoen Clinic Bad Aibling
The purpose of this study is to determine whether galvanic vestibular stimulation is effective in the treatment of spatial neglect after right brain-damage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GVS CL
Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid
Device: Direct current galvanic vestibular stimulation
Other Names:
  • Eldith DC-stimulator manufactured by neuroconn
  • Model-no 0008
  • Serial-no 0028
Experimental: GVS CR
Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid
Device: Direct current galvanic vestibular stimulation
Other Names:
  • Eldith DC-stimulator manufactured by neuroconn
  • Model-no 0008
  • Serial-no 0028
Sham Comparator: GVS Sham
Transmastoid galvanic stimulation set-up is applied, with only 30s of stimulation
Device: Direct current galvanic vestibular stimulation
Other Names:
  • Eldith DC-stimulator manufactured by neuroconn
  • Model-no 0008
  • Serial-no 0028

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective visual vertical due to intervention
Time Frame: Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schoen Clinic Bad Aibling

Collaborators

German Center for Vertigo and Balance Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GVS-Therapy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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