Visual Neglect Clinical Trial
— KMS-Neglect 2Official title:
Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space
| Verified date | November 2018 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité University Medicine | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany | Center for Stroke Research Berlin, Free University of Berlin, Humboldt-Universität zu Berlin, Median Klinik Berlin-Kladow, NeuroCure Clinical Research Center, Charite, Berlin |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | ||
| Secondary | 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. | ||
| Secondary | 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 |