Trial Outcomes & Findings for A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI (NCT NCT04246164)
NCT ID: NCT04246164
Last Updated: 2026-01-28
Results Overview
This measure assesses consent rates and treatment completion amongst subjects by assessing the number of subjects who signed consent forms and the number of completed study visits. In this study, 9 subjects provided informed consent. 1 subject was withdrawn. 8 subjects completed treatment. Therefore, only the data from the 8 subjects who completed treatment were analyzed.
COMPLETED
NA
8 participants
6 months
2026-01-28
Participant Flow
1 subject signed the consent form and withdrew prior to being assigned to one of the treatment arms.
Participant milestones
| Measure |
HD-tDCS Combined With CT
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
Baseline characteristics by cohort
| Measure |
HD-tDCS Combined With CT
n=4 Participants
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
n=4 Participants
sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
8 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=158 Participants
|
4 participants
n=157 Participants
|
8 participants
n=315 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThis measure assesses consent rates and treatment completion amongst subjects by assessing the number of subjects who signed consent forms and the number of completed study visits. In this study, 9 subjects provided informed consent. 1 subject was withdrawn. 8 subjects completed treatment. Therefore, only the data from the 8 subjects who completed treatment were analyzed.
Outcome measures
| Measure |
HD-tDCS Combined With CT
n=4 Participants
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
n=4 Participants
Sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion
Number of subjects who signed consent forms
|
4 Participants
|
4 Participants
|
|
Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion
Number of subjects who completed study treatment
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Alzheimer's Disease Cooperative Study, Preclinical Alzheimer's Cognitive Composite (ADCS-PACC) score at 3 and 6 months from baseline.Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) is a composite of 4 measures with well-established sensitivity for the detection of cognitive decline in prodromal and mild dementia. It is calculated by summing the standardized z-scores of each of the following: * Rey Auditory Verbal Learning Test (0-48 points), Logical Memory IIa sub-test from the Wechsler Memory test (0-25 points) * Mini Mental Status Examination (0-30 points) * Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale-Revised (0-93 points) Z-score of 0 represents the sample mean. A Z-score of 0 indicates average cognitive performance compared to the reference group. For ADCS-PACC, more standard deviations above the mean generally represent a better outcome. There are not specific clinically relevant thresholds universally agreed upon for ADCS-PACC scores. Scores are typically used to compare changes over time.
Outcome measures
| Measure |
HD-tDCS Combined With CT
n=4 Participants
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
n=4 Participants
Sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT
Mean ADCS-PACC at Baseline
|
-0.95975 Z-Score
Standard Deviation 2.2504557131094
|
0.85375 Z-Score
Standard Deviation 3.3297438715313
|
|
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT
Mean ADCS-PACC at Month 3
|
-0.795 Z-Score
Standard Deviation 2.5196990561044
|
1.596 Z-Score
Standard Deviation 3.2651291960146
|
|
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT
Mean ADCS-PACC at Month 6
|
-0.38575 Z-Score
Standard Deviation 3.5756851441367
|
1.227 Z-Score
Standard Deviation 2.764333011777
|
SECONDARY outcome
Timeframe: Measure quality of life in subjects over a period of 3 monthsPopulation: Quality of life questionnaires were removed from study procedures prior to subject enrollment. Therefore, we did not have adequate data to support this outcome measure, so no data is reported. For this reason, no statistical analysis was performed.
Outcome measures
| Measure |
HD-tDCS Combined With CT
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
Sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: We analyzed resting state connectivity changes at Month 3 on MRI
To report the correlation between activation in different brain regions reported. The clinical significance of increasing or reducing connectivity remains unclear. For example, increased connectivity could lead to strengthening of a hypo-functioning network, but reducing connectivity could also be the result of normalizing aberrant and/or compensatory hypo-connectivity. Calculation details: Pearson r correlation coefficients were computed and transformed to Fisher-z. Independent t-test or Wilcoxon Rank Sum analyses were conducted to investigate changes in connectivity from pre- to post-intervention between groups (Active versus Sham). Higher Z-scores (standard deviations above the mean) represent greater functional connectivity (stronger temporal synchronization) between the specified regions of interest (ROIs). Lower Z-scores represent reduced functional connectivity (weaker synchronization). A decrease in Z-scores (lower connectivity) is considered a better outcome.
Outcome measures
| Measure |
HD-tDCS Combined With CT
n=4 Participants
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
n=4 Participants
Sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity
Resting state connectivity changes between left caudal hippocampus and left lateral parietal cortex
|
-0.09065 Z-score
Standard Deviation 0.018280796
|
0.12688 Z-score
Standard Deviation 0.046184866
|
|
Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity
Resting state connectivity changes between right intraparietal sulcus and right frontal eye fields
|
-0.0989 Z-score
Standard Deviation 0.081790097
|
0.11118 Z-score
Standard Deviation 0.046729989
|
Adverse Events
HD-tDCS Combined With CT
Sham HD-tDCS Combined With CT
Serious adverse events
| Measure |
HD-tDCS Combined With CT
n=4 participants at risk
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
n=4 participants at risk
Sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Surgical and medical procedures
Gallbladder removal
|
0.00%
0/4 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
|
Gastrointestinal disorders
Gall stones
|
0.00%
0/4 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
Other adverse events
| Measure |
HD-tDCS Combined With CT
n=4 participants at risk
HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
HD-tDCS combined with CT: HD-tDCS treatments will be administered during a cognitive training session.
|
Sham HD-tDCS Combined With CT
n=4 participants at risk
Sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months.
Sham HD-tDCS combined with CT: sham-HD-tDCS treatments will be administered during a cognitive training session.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
0.00%
0/4 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
|
General disorders
Headache
|
0.00%
0/4 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place