Hypertensive Hemorrhage of Right Parietal LobeGVSNCT02201927
Stimulation Galvanique Vestibulaire
A study testing galvanic vestibular stimulation in people with Hypertensive Hemorrhage of Right Parietal Lobe, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Hemorrhage of Right Parietal Lobe
- What is being tested?
- galvanic vestibular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Oct 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient with right posterieur parietal lobe lesion
- patient with cerebral vascular stroke
- healthy volonteers Age greater than or equal to 18 written informed consent
Who cannot join
- patient's refusal to participate to the study
- inability to cooperate
- cognitive trouble
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions
Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.
- Being tested
- galvanic vestibular stimulation
- Keywords
- galvanic vestibular stimulation, right parietal lobe lesion, egocentric space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galvanic vestibular stimulationDevice
Also called deviation from target score with and without galvanic vestibular stimulation
| Study group | Role | What they receive |
|---|---|---|
| patient with right parietal lobe lesion | Experimental | Patient with right parietal lobe lesion Receives: Device: galvanic vestibular stimulation |
| patient stroke | Experimental | patient with cerebral vascular accident Receives: Device: galvanic vestibular stimulation |
| healthy volunteers | Experimental | healthy volunteers Receives: Device: galvanic vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
deviation from target score
difference in degree between the actual and target score
Measured: 30 min
Secondary outcomes (2)
deviation from target "straight ahead"
difference in degree between the actual straight ahead and target score
Measured: 30min
deviation rightward line bisection
percentage difference between actual and target score on test "deviation right line bisection"
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: lack of performance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Hemorrhage of Right Parietal LobeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- University of Versailles
- Responsible party
- Sponsor
- Investigators
- Ruet Alexis, PHD, Principal investigator, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201927
- Sponsor's protocol ID
- 2013-A01243-42/1
- Acronym
- GVS
- Status last verified
- Feb 2015
- First submitted
- 22 Jul 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions
- ClinicalTrials.gov ID
- NCT02201927
- Acronym / sponsor ID
- GVS / 2013-A01243-42/1
- Keywords
- galvanic vestibular stimulation, right parietal lobe lesion, egocentric space
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of performance
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- University of Versailles
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Jul 2014 (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.
Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient with right parietal lobe lesion | Experimental | Device: galvanic vestibular stimulationPatient with right parietal lobe lesion |
| patient stroke | Experimental | Device: galvanic vestibular stimulationpatient with cerebral vascular accident |
| healthy volunteers | Experimental | Device: galvanic vestibular stimulationhealthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient with right posterieur parietal lobe lesion
- patient with cerebral vascular stroke
- healthy volonteers Age greater than or equal to 18 written informed consent
Key exclusion criteria (4 listed)
- patient's refusal to participate to the study
- inability to cooperate
- cognitive trouble
- epilepsy
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 |
|---|---|---|
| galvanic vestibular stimulationAlso: deviation from target score with and without galvanic vestibular stimulation | Device | healthy volunteers, patient stroke, patient with right parietal lobe lesion |
Primary outcome
deviation from target score
Time frame: 30 min
difference in degree between the actual and target score
2 secondary outcomes
deviation from target "straight ahead"
Time frame: 30min
deviation rightward line bisection
Time frame: 30min
Results and safety
The study was stopped early (reason given: lack of performance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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.
Ruet Alexis, PHD principal investigator
HOPITAL RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing galvanic vestibular stimulation in people with Hypertensive Hemorrhage of Right Parietal Lobe, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Feb 2015. 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 France. 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. 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?
The study was stopped early (reason given: lack of performance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deviation from target score (time frame: 30 min). 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 3 Feb 2015.