NCT01834443

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

April 3, 2013

Last Update Submit

April 15, 2013

Conditions

Spatial Neglect After Right Brain-damage

Keywords

spatial neglectgalvanic vestibular stimulation as therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • 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)

Other Outcomes (1)

  • Change in subjective visual 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)

Study Arms (3)

GVS CL

EXPERIMENTAL

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

Device: Direct current galvanic vestibular stimulation

GVS CR

EXPERIMENTAL

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

Device: Direct current galvanic vestibular stimulation

GVS Sham

SHAM COMPARATOR

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

Device: Direct current galvanic vestibular stimulation

Interventions

Direct current galvanic vestibular stimulationDEVICE
Also known as: Eldith DC-stimulator manufactured by neuroconn, Model-no 0008, Serial-no 0028
GVS CLGVS CRGVS Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spatial neglect after unilateral ischemic infarction or unilateral haemorrhage

You may not qualify if:

  • Chronic epilepsy
  • Metallic implants (including pacemakers)
  • Brain tumors
  • Scalp inflammation
  • Degenerative disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Clinic Bad Aibling

Bad Aibling, Bavaria, 83043, Germany

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 17, 2013

Study Start

May 1, 2011

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

DE(1)