Spatial Neglect After Right Brain-damageGVSNCT01834443
Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect
A study testing Direct current galvanic vestibular stimulation in people with Spatial Neglect After Right Brain-damage, run by Schoen Clinic Bad Aibling at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spatial Neglect After Right Brain-damage
- What is being tested?
- Direct current galvanic vestibular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spatial neglect after unilateral ischemic infarction or unilateral haemorrhage
Who cannot join
- Chronic epilepsy
- Metallic implants (including pacemakers)
- Brain tumors
- Scalp inflammation
- Degenerative disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Clinic Bad Aibling
Bad Aibling, Bavaria, 83043
Katharina Volkening, M.Sc., +4980619031903, KVolkening@schoen-kliniken.de
Ingo Keller, Prof. Dr., IKeller@schoen-kliniken.de
About this study
The purpose of this study is to determine whether galvanic vestibular stimulation is effective in the treatment of spatial neglect after right brain-damage.
- Conditions
- Spatial Neglect After Right Brain-damage
- Being tested
- Direct current galvanic vestibular stimulation
- Keywords
- spatial neglect, galvanic vestibular stimulation as therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct current galvanic vestibular stimulationDevice
Also called Eldith DC-stimulator manufactured by neuroconn, Model-no 0008, Serial-no 0028
| Study group | Role | What they receive |
|---|---|---|
| GVS CL | Experimental | Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid Receives: Device: Direct current galvanic vestibular stimulation |
| GVS CR | Experimental | Transmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid Receives: Device: Direct current galvanic vestibular stimulation |
| GVS Sham | Sham comparator | Transmastoid galvanic stimulation set-up is applied, with only 30s of stimulation Receives: Device: Direct current galvanic vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neglect Test (NET)due to intervention, the German version of the Behavioral Inattention Test (BIT)
Measured: 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
Subjects searches objects glued to a board, the time needed to do so is measured
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
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.
Measured: Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial Neglect After Right Brain-damageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schoen Clinic Bad Aibling
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Vertigo and Balance Disorders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834443
- Sponsor's protocol ID
- GVS-Therapy
- Acronym
- GVS
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2013
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect
- ClinicalTrials.gov ID
- NCT01834443
- Acronym / sponsor ID
- GVS / GVS-Therapy
- Conditions
- Spatial Neglect After Right Brain-damage
- Keywords
- spatial neglect, galvanic vestibular stimulation as therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Schoen Clinic Bad AiblingUniversity, hospital or other
- Collaborators
- German Center for Vertigo and Balance Disorders
- Study start
- May 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GVS CL | Experimental | Device: Direct current galvanic vestibular stimulationTransmastoid galvanic vestibular stimulation is applied, with the cathode placed on the left mastoid |
| GVS CR | Experimental | Device: Direct current galvanic vestibular stimulationTransmastoid galvanic vestibular stimulation is applied, with the cathode placed on the right mastoid |
| GVS Sham | Sham comparator | Device: Direct current galvanic vestibular stimulationTransmastoid galvanic stimulation set-up is applied, with only 30s of stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- spatial neglect after unilateral ischemic infarction or unilateral haemorrhage
Key exclusion criteria (5 listed)
- Chronic epilepsy
- Metallic implants (including pacemakers)
- Brain tumors
- Scalp inflammation
- Degenerative disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct current galvanic vestibular stimulationAlso: Eldith DC-stimulator manufactured by neuroconn, Model-no 0008, Serial-no 0028 | Device | GVS CL, GVS CR, GVS Sham |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct current galvanic vestibular stimulation in people with Spatial Neglect After Right Brain-damage, run by Schoen Clinic Bad Aibling at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.