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This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or sham tDCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum tDCS | Experimental | Left frontal anodal stimulation, supraorbital right cathodal stimulation |
|
| Sham tDCS | Experimental | sham stimulation, same electrode positions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum tDCS | Device | Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anodal, right cathodal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT) | The Investigators are measuring cognitive performance for different executive functions, here the score (percentile of the norm values) of the test verbal learning memory test (VLMT), parameter immediate recall post treatment is reported. Rage from 0 to 100 %. Higher values indicate higher performance. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT) | NIRS is a brain imaging method, with the parameters of oxy (OxyHB) and deoxy (deoxyHB) hemoglobin. Activation is reflected by increase of OxyHB and decrease DeoxyHB. Differences from pre- to post-measurement for OxyHB are reported in a region of interest analysis of the dorsolateral prefrontal cortex. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin J. Herrmann, PD Dr | University of Würzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Würzburg | 97080 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum tDCS | Left frontal anodal stimulation, supraorbital right cathodal stimulation Verum tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anadal, right cathodal |
| FG001 | Sham tDCS | sham stimulation, same electrode positions Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum tDCS | Left frontal anodal stimulation, supraorbital right cathodal stimulation Verum tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anadal, right cathodal |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT) | The Investigators are measuring cognitive performance for different executive functions, here the score (percentile of the norm values) of the test verbal learning memory test (VLMT), parameter immediate recall post treatment is reported. Rage from 0 to 100 %. Higher values indicate higher performance. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum tDCS | Left frontal anodal stimulation, supraorbital right cathodal stimulation Verum tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anadal, right cathodal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Martin Herrmann | Universitätsklinikum Würzburg | +4993120176650 | Herrmann_m@ukw.de |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Sham tDCS | Device | Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere |
|
| 4 weeks |
sham stimulation, same electrode positions Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
sham stimulation, same electrode positions
Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
|
|
|
| Secondary | Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT) | NIRS is a brain imaging method, with the parameters of oxy (OxyHB) and deoxy (deoxyHB) hemoglobin. Activation is reflected by increase of OxyHB and decrease DeoxyHB. Differences from pre- to post-measurement for OxyHB are reported in a region of interest analysis of the dorsolateral prefrontal cortex. | Posted | Mean | Standard Deviation | Unit of Measure: Δ mol/L | 4 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sham tDCS | sham stimulation, same electrode positions Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere | 0 | 18 | 0 | 18 | 0 | 18 |
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