Mild Cognitive Impairment
Conditions
Keywords
Subjective Memory Impairment, tDCS, NIRS, Cognitive Training, Working Memory
Brief summary
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.
Interventions
DEVICEVerum tDCS
Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anodal, right cathodal
DEVICESham tDCS
Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* native german speaker * between 60-70 years old * subjective memory impairment
Exclusion criteria
* psychiatric, neurological diseases * uncorrected hearing or vision deficits * actual psychopharmaco intake * metal parts in the head * medical electronical implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT) | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT) | 4 weeks | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Sham tDCS sham stimulation, same electrode positions
Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere | 18 |
| Total | 38 |
Baseline characteristics
| Characteristic | Verum tDCS | Total | Sham tDCS |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 3 | 64.2 years STANDARD_DEVIATION 2.7 | 64.2 years STANDARD_DEVIATION 2.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 38 Participants | 18 Participants |
| Region of Enrollment Germany | 20 participants | 38 participants | 18 participants |
| Sex: Female, Male Female | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 18 |
| other Total, other adverse events | 0 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verum tDCS | Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT) | 57.2 score on a scale | Standard Deviation 9.4 |
| Sham tDCS | Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT) | 57.2 score on a scale | Standard Deviation 5.1 |
p-value: 0.74ANOVA
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verum tDCS | Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT) | -12.43 Unit of Measure: Δ mol/L | Standard Deviation 13.37 |
| Sham tDCS | Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT) | -3.68 Unit of Measure: Δ mol/L | Standard Deviation 14.66 |
p-value: 0.062t-test, 2 sided