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

Primary Purpose

Spatial Neglect After Right Brain-damage

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Direct current galvanic vestibular stimulation
Sponsored by
Schoen Clinic Bad Aibling
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spatial Neglect After Right Brain-damage focused on measuring spatial neglect, galvanic vestibular stimulation as therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schoen Clinic Bad AiblingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

GVS CL

GVS CR

GVS Sham

Arm Description

Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid

Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid

Transmastoid galvanic stimulation set-up is applied, with only 30s of stimulation

Outcomes

Primary Outcome Measures

Change in Neglect Test (NET)due to intervention, the German version of the Behavioral Inattention Test (BIT)

Secondary Outcome Measures

Change in visual-tactile search task due to intervention
Subjects searches objects glued to a board, the time needed to do so is measured
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.

Full Information

First Posted
April 3, 2013
Last Updated
April 15, 2013
Sponsor
Schoen Clinic Bad Aibling
Collaborators
German Center for Vertigo and Balance Disorders
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1. Study Identification

Unique Protocol Identification Number
NCT01834443
Brief Title
Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect
Acronym
GVS
Official Title
Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schoen Clinic Bad Aibling
Collaborators
German Center for Vertigo and Balance Disorders

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect After Right Brain-damage
Keywords
spatial neglect, galvanic vestibular stimulation as therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GVS CL
Arm Type
Experimental
Arm Description
Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid
Arm Title
GVS CR
Arm Type
Experimental
Arm Description
Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid
Arm Title
GVS Sham
Arm Type
Sham Comparator
Arm Description
Transmastoid galvanic stimulation set-up is applied, with only 30s of stimulation
Intervention Type
Device
Intervention Name(s)
Direct current galvanic vestibular stimulation
Other Intervention Name(s)
Eldith DC-stimulator manufactured by neuroconn, Model-no 0008, Serial-no 0028
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Change in visual-tactile search task due to intervention
Description
Subjects searches objects glued to a board, the time needed to do so is measured
Time Frame
Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
Title
Change in subjective haptic vertical due to intervention
Description
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.
Time Frame
Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
Other Pre-specified Outcome Measures:
Title
Change in subjective visual vertical due to intervention
Description
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.
Time Frame
Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Schoen Clinic Bad Aibling
City
Bad Aibling
State/Province
Bavaria
ZIP/Postal Code
83043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Volkening, M.Sc.
Phone
+4980619031903
Email
KVolkening@schoen-kliniken.de
First Name & Middle Initial & Last Name & Degree
Ingo Keller, Prof. Dr.
Email
IKeller@schoen-kliniken.de

12. IPD Sharing Statement

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

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