Visual NeglectKMS-Neglect 2NCT01740544
Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space
A study testing Cathodal tDCS in people with Visual Neglect, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann \& Fimm, 1993). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Neglect
- What is being tested?
- Cathodal tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2012
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Younger subjects
- aged between 18 and 35 years
- ability to provide written informed consent
- right-handedness
- Elderly subjects
- aged between 50 and 85 years
- ability to provide written informed consent
- right-handedness
Who cannot join
- Exclusion criteria for both groups:
- serious psychiatric disorders (including depression, psychosis) in the past
- severe neurological disorders (such as epilepsy, dementia, stroke) in the past
- current severe medical disorder
- drugs, medication or alcohol abuse at the time of the study
- severe traumatic brain injury or tumor in the past
Show all 13Show fewer
- operations on the brain, trepanations
- metallic implants in the head / neck area (except in the mouth), such as screws, splinter, artificial cochlea, electrodes
- severe skin diseases (like eczema) or very sensitive skin in the head region in the past
- epilepsy in the family
- current use of neuroleptics, antiepileptics, antidepressants, L-dopa, benzo-diazepines
- current pregnancy or lactation
- current claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann \& Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to poorer test performance.
- Conditions
- Visual Neglect
- Being tested
- Cathodal tDCS, Sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal tDCSOther
Cathodal tDCS applied over the right PPC
Sham tDCSOther
Sham tDCS applied over the right PPC
| Study group | Role | What they receive |
|---|---|---|
| Cathodal tDCS in young study participants | Experimental | Cathodal tDCS in young study participants Receives: Other: Cathodal tDCS |
| Cathodal tDCS in elderly study participants | Experimental | Cathodal tDCS in elderly study participants Receives: Other: Cathodal tDCS |
| Sham tDCS in young study participants | Sham comparator | Sham tDCS in young study participants Receives: Other: Sham tDCS |
| Sham tDCS in elderly study participants | Sham comparator | Sham tDCS in elderly study participants Receives: Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test performance of young study participants in the encircling monitor system with/without cathodal stimulation
Comparison of the young subjects' performance with vs. without transcranial direct current stimulation (tDCS) in the following computerised tests: Star Cancellation (number of omissions, latency \& crossing index; based on Rabufetti, 2012), Landmark (reaction times, accuracy; based on Giglia et al., 2011), Visual Detection (reaction times, omissions; based on Sparing et al., 2009), Extinction (number of correct responses; based on Niedeggen \& Hoffmann, 2011)
Secondary outcomes (3)
Test performance of elderly study participants in the encircling monitor system with/without cathodal stimulation
Comparison of the performance with vs. without transcranial direct current stimulation (tDCS) in the following tests: Star Cancellation, Landmark, Visual Detection, Extinction (see above)
Test performance of study participants in the Test Battery for Attention Performance (TAP) with/without cathodal stimulation
Comparison of reaction times and number of omissions in the left and right visual field in the TAP subtest "Neglect" with vs. without tDCS.
Comparison of visual search patterns between neglect patients and healthy subjects with cathodal stimulation
Comparison of visual search direction, structuredness (crossing index), and omissions in the Star Cancellation Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Median Klinik Berlin-Kladow, NeuroCure Clinical Research Center, Charite, Berlin, Center for Stroke Research Berlin, Free University of Berlin, Humboldt-Universität zu Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, MD, Principal investigator, Charite - Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740544
- Sponsor's protocol ID
- KMS-Neglect 2
- Acronym
- KMS-Neglect 2
- Status last verified
- Nov 2018
- First submitted
- 27 Jul 2012
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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
- Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space
- ClinicalTrials.gov ID
- NCT01740544
- Acronym / sponsor ID
- KMS-Neglect 2 / KMS-Neglect 2
- Conditions
- Visual Neglect
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Median Klinik Berlin-Kladow, NeuroCure Clinical Research Center, Charite, Berlin, Center for Stroke Research Berlin, Free University of Berlin, Humboldt-Universität zu Berlin
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Dec 2012 (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.
Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann \& Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to poorer test performance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cathodal tDCS in young study participants | Experimental | Other: Cathodal tDCSCathodal tDCS in young study participants |
| Cathodal tDCS in elderly study participants | Experimental | Other: Cathodal tDCSCathodal tDCS in elderly study participants |
| Sham tDCS in young study participants | Sham comparator | Other: Sham tDCSSham tDCS in young study participants |
| Sham tDCS in elderly study participants | Sham comparator | Other: Sham tDCSSham tDCS in elderly study participants |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Younger subjects
- Elderly subjects
Key exclusion criteria (13 listed)
- Exclusion criteria for both groups:
- serious psychiatric disorders (including depression, psychosis) in the past
- severe neurological disorders (such as epilepsy, dementia, stroke) in the past
- current severe medical disorder
- drugs, medication or alcohol abuse at the time of the study
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 |
|---|---|---|
| Cathodal tDCSCathodal tDCS applied over the right PPC | Other | Cathodal tDCS in elderly study participants, Cathodal tDCS in young study participants |
| Sham tDCSSham tDCS applied over the right PPC | Other | Sham tDCS in elderly study participants, Sham tDCS in young study participants |
Primary outcome
Test performance of young study participants in the encircling monitor system with/without cathodal stimulation
Comparison of the young subjects' performance with vs. without transcranial direct current stimulation (tDCS) in the following computerised tests: Star Cancellation (number of omissions, latency \& crossing index; based on Rabufetti, 2012), Landmark (reaction times, accuracy; based on Giglia et al., 2011), Visual Detection (reaction times, omissions; based on Sparing et al., 2009), Extinction (number of correct responses; based on Niedeggen \& Hoffmann, 2011)
3 secondary outcomes
Test performance of elderly study participants in the encircling monitor system with/without cathodal stimulation
Test performance of study participants in the Test Battery for Attention Performance (TAP) with/without cathodal stimulation
Comparison of visual search patterns between neglect patients and healthy subjects with cathodal stimulation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
Related trials for Visual Neglect
Recruiting
Implementation of IVS3 for Upper Limb Motor Recovery
Neglect, Hemispatial, Stroke, Cardiovascular
Not yet recruiting
Cerebellum and Neglect
Hemispatial Neglect, Visual Neglect
Recruiting
Standardization of Spatial Neglect Assessment Tests
Perceptual Disorders, Healthy Volunteers
Not yet recruiting
Mixed-Reality Visual Attention Task for Neglect Diagnosis and Rehabilitation
Neglect, Sensory, Neglect, Hemispatial
RecruitingObservational study
Investigating Visual Verticality Disorder and Lateropulsion in a Neurosurgical Cohort of Patients With Brain Tumours
Brain Tumours
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 - Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cathodal tDCS in people with Visual Neglect, 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 8 inclusion and 13 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 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. 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?
The study was stopped early. 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?
Test performance of young study participants in the encircling monitor system with/without cathodal stimulation. 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 29 Nov 2018.