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

NCT ID: NCT01834443

Last Updated: 2013-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-03-31

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.

Detailed Description

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Conditions

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Spatial Neglect After Right Brain-damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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GVS CL

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

Group Type EXPERIMENTAL

Direct current galvanic vestibular stimulation

Intervention Type DEVICE

GVS CR

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

Group Type EXPERIMENTAL

Direct current galvanic vestibular stimulation

Intervention Type DEVICE

GVS Sham

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

Group Type SHAM_COMPARATOR

Direct current galvanic vestibular stimulation

Intervention Type DEVICE

Interventions

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Direct current galvanic vestibular stimulation

Intervention Type DEVICE

Other Intervention Names

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Eldith DC-stimulator manufactured by neuroconn Model-no 0008 Serial-no 0028

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Center for Vertigo and Balance Disorders

OTHER

Sponsor Role collaborator

Schoen Clinic Bad Aibling

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Schoen Clinic Bad Aibling

Bad Aibling, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Katharina Volkening, M.Sc.

Role: primary

+4980619031903

Ingo Keller, Prof. Dr.

Role: backup

Other Identifiers

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GVS-Therapy

Identifier Type: -

Identifier Source: org_study_id

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