Trial Outcomes & Findings for Brain Stimulation and Cognitive Training - Efficacy (NCT NCT05111548)
NCT ID: NCT05111548
Last Updated: 2024-05-09
Results Overview
MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Baseline to post-treatment (up to 4 weeks)
Results posted on
2024-05-09
Participant Flow
Two participants did not meet the inclusion criteria and were excluded from further participation (i.e., screen failures). Two participants withdrew from the study after enrollment and prior to randomization. Therefore, 19 participants were enrolled and 15 were assigned.
Participant milestones
| Measure |
Active Stimulation + Cognitive Training
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Active Stimulation + Cognitive Training
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Brain Stimulation and Cognitive Training - Efficacy
Baseline characteristics by cohort
| Measure |
Active Stimulation + Cognitive Training
n=8 Participants
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
n=7 Participants
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.63 years
STANDARD_DEVIATION 8.43 • n=39 Participants
|
34.71 years
STANDARD_DEVIATION 11.43 • n=41 Participants
|
33.07 years
STANDARD_DEVIATION 9.70 • n=35 Participants
|
|
Sex/Gender, Customized
Woman
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex/Gender, Customized
Man
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
MCCB spatial span total score
|
17.25 points on a scale
STANDARD_DEVIATION 2.87 • n=39 Participants
|
15.57 points on a scale
STANDARD_DEVIATION 4.65 • n=41 Participants
|
16.47 points on a scale
STANDARD_DEVIATION 3.76 • n=35 Participants
|
|
MCCB letter-number span total score
|
15.38 points on a scale
STANDARD_DEVIATION 3.38 • n=39 Participants
|
15.43 points on a scale
STANDARD_DEVIATION 3.60 • n=41 Participants
|
15.40 points on a scale
STANDARD_DEVIATION 3.36 • n=35 Participants
|
|
MCCB Trail Making Test, part A
|
22.50 seconds
STANDARD_DEVIATION 6.09 • n=39 Participants
|
23.14 seconds
STANDARD_DEVIATION 4.98 • n=41 Participants
|
22.80 seconds
STANDARD_DEVIATION 5.41 • n=35 Participants
|
|
Trail Making Test, part B
|
60.50 seconds
STANDARD_DEVIATION 11.67 • n=39 Participants
|
72.71 seconds
STANDARD_DEVIATION 24.94 • n=41 Participants
|
66.20 seconds
STANDARD_DEVIATION 19.35 • n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (up to 4 weeks)Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).
Outcome measures
| Measure |
Active Stimulation + Cognitive Training
n=5 Participants
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
n=6 Participants
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score
|
0.40 score on a scale
Standard Deviation 1.67
|
0.50 score on a scale
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (up to 4 weeks)Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).
Outcome measures
| Measure |
Active Stimulation + Cognitive Training
n=5 Participants
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
n=6 Participants
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
|
1.60 score on a scale
Standard Deviation 0.89
|
0.17 score on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (up to 4 weeks)Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
The Trail Making Test, part A is a subtest of the standardized MCCB and a measure of visuomotor processing/sequencing speed. Examinees must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).
Outcome measures
| Measure |
Active Stimulation + Cognitive Training
n=5 Participants
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
n=6 Participants
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A
|
1.40 seconds
Standard Deviation 5.55
|
2.33 seconds
Standard Deviation 7.17
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (up to 4 weeks)Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
Trail Making Test, part B is not part of the standardized MCCB, but is commonly administered alongside part A as a measure of speeded visuomotor switching/flexibility. Examinees must draw a line connecting numbers and letters in alternating order (e.g., 1-A-2-B). Completion time in seconds is recorded (0-300, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).
Outcome measures
| Measure |
Active Stimulation + Cognitive Training
n=5 Participants
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
n=6 Participants
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B
|
3.60 seconds
Standard Deviation 12.82
|
19.50 seconds
Standard Deviation 17.76
|
Adverse Events
Active Stimulation + Cognitive Training
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Inactive Stimulation + Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Stimulation + Cognitive Training
n=8 participants at risk
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Inactive Stimulation + Cognitive Training
n=7 participants at risk
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Intense discomfort at stimulation site
|
12.5%
1/8 • Number of events 1 • Duration of participation in the study (i.e., up to 8 weeks).
|
0.00%
0/7 • Duration of participation in the study (i.e., up to 8 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place