Trial Outcomes & Findings for Cognitive Ability Training in Seniors (NCT NCT02587338)
NCT ID: NCT02587338
Last Updated: 2024-03-12
Results Overview
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.
COMPLETED
NA
38 participants
4 weeks
2024-03-12
Participant Flow
Participant milestones
| Measure |
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
|
Sham tDCS
sham stimulation, same electrode positions
Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Ability Training in Seniors
Baseline characteristics by cohort
| Measure |
Verum tDCS
n=20 Participants
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
|
Sham tDCS
n=18 Participants
sham stimulation, same electrode positions
Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 3.0 • n=99 Participants
|
64.2 years
STANDARD_DEVIATION 2.5 • n=107 Participants
|
64.2 years
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe 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.
Outcome measures
| Measure |
Verum tDCS
n=20 Participants
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
|
Sham tDCS
n=18 Participants
sham stimulation, same electrode positions
Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
|
|---|---|---|
|
Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT)
|
57.2 score on a scale
Standard Deviation 9.4
|
57.2 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 4 weeksNIRS 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.
Outcome measures
| Measure |
Verum tDCS
n=20 Participants
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
|
Sham tDCS
n=18 Participants
sham stimulation, same electrode positions
Sham tDCS: Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
|
|---|---|---|
|
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
|
-3.68 Unit of Measure: Δ mol/L
Standard Deviation 14.66
|
Adverse Events
Verum tDCS
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. Martin Herrmann
Universitätsklinikum Würzburg
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place