Trial Outcomes & Findings for SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults (NCT NCT05377411)
NCT ID: NCT05377411
Last Updated: 2025-06-26
Results Overview
Change in working memory performance on the N back working memory MRI task from baseline to post test will be assessed. Post test will occur approximately two weeks following baseline. The N-back working memory task will be completed during the MRI scan at both baseline and post test assessments. Working memory performance will be defined as a composite of reaction time and accuracy for two back trials. Specifically Target Accuracy percent correct and average correct target reaction time in milliseconds. Percent changes were calculated for Target Accuracy and Reaction Time in the form of (post test-pre test)/pre test. Since the direction of improvement is opposite for the two variables (i.e. higher Accuracy is better and lower Reaction Time is better), the reaction time percent change was multiplied by -1 to ensure a larger number indicated improved performance. To create a composite these two percent changes (Target Accuracy and Reaction Time) were averaged into a single value.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Baseline to post test. Post test will occur approximately two weeks following baseline.
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
Optimized tDCS + Cognitive Training
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of up to 4.0mA direct current through two biocarbon rubber electrodes covered with at least 5mm-thick conductive electrode paste buffer, and placed over the optimized locations based on the international 10-20 system by using a combination of 10-20 EEG cap measurement and a stereotactic neuronavigation system. Stereotactic neuronavigation will be used as needed and may not be used on all participants.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
Sham tDCS + Cognitive Training
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of up to 4 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
Baseline characteristics by cohort
| Measure |
Optimized tDCS + Cognitive Training
n=17 Participants
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of up to 4.0mA direct current through two biocarbon rubber electrodes covered with at least 5mm-thick conductive electrode paste buffer, and placed over the optimized locations based on the international 10-20 system by using a combination of 10-20 EEG cap measurement and a stereotactic neuronavigation system. Stereotactic neuronavigation will be used as needed and may not be used on all participants.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
Sham tDCS + Cognitive Training
n=16 Participants
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of up to 4 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.65 years
STANDARD_DEVIATION 5.31 • n=5 Participants
|
72.25 years
STANDARD_DEVIATION 5.86 • n=7 Participants
|
72.45 years
STANDARD_DEVIATION 5.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to post test. Post test will occur approximately two weeks following baseline.Change in working memory performance on the N back working memory MRI task from baseline to post test will be assessed. Post test will occur approximately two weeks following baseline. The N-back working memory task will be completed during the MRI scan at both baseline and post test assessments. Working memory performance will be defined as a composite of reaction time and accuracy for two back trials. Specifically Target Accuracy percent correct and average correct target reaction time in milliseconds. Percent changes were calculated for Target Accuracy and Reaction Time in the form of (post test-pre test)/pre test. Since the direction of improvement is opposite for the two variables (i.e. higher Accuracy is better and lower Reaction Time is better), the reaction time percent change was multiplied by -1 to ensure a larger number indicated improved performance. To create a composite these two percent changes (Target Accuracy and Reaction Time) were averaged into a single value.
Outcome measures
| Measure |
Optimized tDCS + Cognitive Training
n=16 Participants
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of up to 4.0mA direct current through two biocarbon rubber electrodes covered with at least 5mm-thick conductive electrode paste buffer, and placed over the optimized locations based on the international 10-20 system by using a combination of 10-20 EEG cap measurement and a stereotactic neuronavigation system. Stereotactic neuronavigation will be used as needed and may not be used on all participants.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
Sham tDCS + Cognitive Training
n=15 Participants
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of up to 4 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
|---|---|---|
|
N-Back Working Memory
|
.2030 percent change
Standard Deviation .3164
|
.0731 percent change
Standard Deviation .1404
|
Adverse Events
Optimized tDCS + Cognitive Training
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham tDCS + Cognitive Training
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Optimized tDCS + Cognitive Training
n=17 participants at risk
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of up to 4.0mA direct current through two biocarbon rubber electrodes covered with at least 5mm-thick conductive electrode paste buffer, and placed over the optimized locations based on the international 10-20 system by using a combination of 10-20 EEG cap measurement and a stereotactic neuronavigation system. Stereotactic neuronavigation will be used as needed and may not be used on all participants.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
Sham tDCS + Cognitive Training
n=16 participants at risk
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of up to 4 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
tDCS: During tDCS, a weak electrical current is applied to the scalp that penetrates skin, bone, CSF and the meninges to stimulate underlying cortical and subcortical tissue
cognitive training: Cognitive Training (CT) will involve up to 10 hours of training over 2-weeks (10 days). CT employs a PositScience BrainHQ suite via its researcher portal. These tasks are web-based and multi-platform (i.e., Windows, Mac). Participants will be randomly assigned to training on 4 tasks focusing on working memory or 4 tasks focusing on attention/speed of processing.
|
|---|---|---|
|
General disorders
Headache
|
23.5%
4/17 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
18.8%
3/16 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
|
Eye disorders
Eye Redness
|
5.9%
1/17 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
6.2%
1/16 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/17 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
6.2%
1/16 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
0.00%
0/16 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
|
General disorders
Car accident
|
5.9%
1/17 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
0.00%
0/16 • 2 weeks. Adverse events were collected from study enrollment (week 0) until post-test (week 2).
Adverse events were collected at baseline and post-test assessments via medical questionnaires. Adverse events could be reported outside of baseline and post-test assessments via participant self-reporting to experimenters during the approximate two week period of intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place