Spatial NeglectKMS-NeglectNCT01399073
Virtual Reality for Neglect Diagnostics
An observational study of Spatial Neglect and Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Neglect, Stroke
- What is being tested?
- virtual reality setup, paper and pencil tests and c-mri
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Jul 2012
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute (< 2 wks after stroke), subacute (2 wks- 3 months after stroke)or chronic (3- 24 months after stroke)stroke with neglect or hemianopsia. Healthy, age-matched controls.
Who may be able to join
- age ≥18 and <80 years
- first stroke
- neglect symptoms
- no hemianopsia symptoms
- consent given by the patient
- age ≥18 and <80 years
Show all 13Show fewer
- first stroke
- no neglect symptoms
- hemianopsia symptoms
- consent given by the patient
- age ≥18 and <80 years
- no neurological deficits
- informed consent
Who cannot join
- language comprehension deficits
- motor deficits of the upper extremities
- cognitive impairments (MMSE <20 or SKT >15 or DEMTEC >12)
- depression
- seizure disorders
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.
- Conditions
- Spatial Neglect, Stroke
- Being tested
- virtual reality setup, paper and pencil tests, c-mri
- Keywords
- stroke, neglect, hemianopsia, virtual reality
- Medical subject headings
- Stroke, Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality setupBehavioural
testing for neglect in a virtual reality setup
paper and pencil testsBehavioural
testing for neglect with the classical paper-and-pencil tests
c-mriOther
structural and functional (resting state) imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with Neglect | Not described Receives: Behavioral: virtual reality setup; Behavioral: paper and pencil tests; Other: c-mri | |
| Patients with Hemianopsia | Not described Receives: Behavioral: virtual reality setup; Behavioral: paper and pencil tests; Other: c-mri | |
| Healthy age-matched controls | Not described Receives: Behavioral: virtual reality setup; Behavioral: paper and pencil tests; Other: c-mri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility of the use of a virtual reality setup in the diagnostics of neglect
Measured: within the first 2 years after stroke
Secondary outcomes (2)
Sensitivity and Specificity
The diagnostics of neglect via a virtual reality setup is more sensitive and more specific than the standard diagnostics via "paper-and-pencil" Tests
Measured: within the first 2 years after stroke
mri (functional (resting state) and structural imaging
We hypothesize that there are connectivity-based differences in the different stages of neglect and anatomical and functional connectivity correlates with respect to behavioural impairment.
Measured: within the first 2 years after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spatial NeglectStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Median Klinik Kladow, Freie Universität Berlin, Berlin Center for Advanced Neuroimaging, Humboldt-Universität zu Berlin, NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, MD, Principal investigator, Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399073
- Sponsor's protocol ID
- KMS-Neglect
- Acronym
- KMS-Neglect
- Status last verified
- Nov 2018
- First submitted
- 8 Jul 2011
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ulm L, Wohlrapp D, Meinzer M, Steinicke R, Schatz A, Denzler P, Klehmet J, Dohle C, Niedeggen M, Meisel A, Winter Y. A circle-monitor for computerised assessment of visual neglect in peripersonal space. PLoS One. 2013 Dec 12;8(12):e82892. doi: 10.1371/journal.pone.0082892. eCollection 2013.
PubMed 24349387
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Neglect Diagnostics
- ClinicalTrials.gov ID
- NCT01399073
- Acronym / sponsor ID
- KMS-Neglect / KMS-Neglect
- Conditions
- Spatial Neglect, Stroke
- Keywords
- stroke, neglect, hemianopsia, virtual reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Median Klinik Kladow, Freie Universität Berlin, Berlin Center for Advanced Neuroimaging, Humboldt-Universität zu Berlin, NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- May 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Jul 2011 (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.
Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Neglect | – | Behavioral: virtual reality setup, Behavioral: paper and pencil tests, Other: c-mri |
| Patients with Hemianopsia | – | Behavioral: virtual reality setup, Behavioral: paper and pencil tests, Other: c-mri |
| Healthy age-matched controls | – | Behavioral: virtual reality setup, Behavioral: paper and pencil tests, Other: c-mri |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute (< 2 wks after stroke), subacute (2 wks- 3 months after stroke)or chronic (3- 24 months after stroke)stroke with neglect or hemianopsia. Healthy, age-matched controls.
Key inclusion criteria (13 listed)
- age ≥18 and <80 years
- first stroke
- neglect symptoms
- no hemianopsia symptoms
- consent given by the patient
Key exclusion criteria (6 listed)
- language comprehension deficits
- motor deficits of the upper extremities
- cognitive impairments (MMSE <20 or SKT >15 or DEMTEC >12)
- depression
- seizure disorders
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 |
|---|---|---|
| virtual reality setuptesting for neglect in a virtual reality setup | Behavioural | Healthy age-matched controls, Patients with Hemianopsia, Patients with Neglect |
| paper and pencil teststesting for neglect with the classical paper-and-pencil tests | Behavioural | Healthy age-matched controls, Patients with Hemianopsia, Patients with Neglect |
| c-mristructural and functional (resting state) imaging | Other | Healthy age-matched controls, Patients with Hemianopsia, Patients with Neglect |
Primary outcome
Feasibility
Time frame: within the first 2 years after stroke
Feasibility of the use of a virtual reality setup in the diagnostics of neglect
2 secondary outcomes
Sensitivity and Specificity
Time frame: within the first 2 years after stroke
mri (functional (resting state) and structural imaging
Time frame: within the first 2 years after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Results publication: PubMed 24349387Ulm L, Wohlrapp D, Meinzer M, Steinicke R, Schatz A, Denzler P, Klehmet J, Dohle C, Niedeggen M, Meisel A, Winter Y. A circle-monitor for computerised assessment of visual neglect in peripersonal space. PLoS One. 2013 Dec 12;8(12):e82892. doi: 10.1371/journal.pone.0082892. eCollection 2013.
Related trials for Spatial Neglect
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Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
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Dosing and Deployment Trial: A Home-based Optokinetic Treatment
Spatial Neglect
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Spatial-Motor Stroke-Rehab Study
Spatial Neglect, Stroke
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Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Recruiting
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
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.
Andreas Meisel, MD principal investigator
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spatial Neglect and Stroke, run by Charite University, Berlin, Germany 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 13 inclusion and 6 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: finished, as of the sponsor's last update on 29 Nov 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility (time frame: within the first 2 years after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399073, which also lists 1 linked publication.
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 29 Nov 2018.