Trial Outcomes & Findings for Brain Stimulation and Cognitive Training (NCT NCT03338673)
NCT ID: NCT03338673
Last Updated: 2020-09-02
Results Overview
Number of participants completing every session of the combined phase of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Dual Therapy First
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Mono Therapy First
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dual Therapy First
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Mono Therapy First
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Brain Stimulation and Cognitive Training
Baseline characteristics by cohort
| Measure |
Dual Therapy First
n=6 Participants
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Mono Therapy First
n=6 Participants
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.67 years
STANDARD_DEVIATION 13.98 • n=39 Participants
|
48.83 years
STANDARD_DEVIATION 13.41 • n=41 Participants
|
48.75 years
STANDARD_DEVIATION 13.06 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 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
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 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
|
PRIMARY outcome
Timeframe: 4 weeksNumber of participants completing every session of the combined phase of treatment
Outcome measures
| Measure |
Dual Therapy First
n=6 Participants
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Mono Therapy First
n=6 Participants
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
|---|---|---|
|
Participant Retention in Combination Treatment
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksSelf-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)
Outcome measures
| Measure |
Dual Therapy First
n=5 Participants
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
Mono Therapy First
n=5 Participants
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
|---|---|---|
|
Participant-rated Acceptability of Combination Therapy
|
9.40 units on a scale
Standard Deviation 0.89
|
8.60 units on a scale
Standard Deviation 2.07
|
Adverse Events
Dual Therapy First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mono Therapy First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place