Trial Outcomes & Findings for Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS) (NCT NCT05408975)
NCT ID: NCT05408975
Last Updated: 2026-02-02
Results Overview
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.
COMPLETED
NA
5 participants
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
2026-02-02
Participant Flow
Participant milestones
| Measure |
Active to Sham Transcranial Direct Current Stimulation
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active Transcranial Direct Current Stimulation
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Baseline
STARTED
|
3
|
2
|
|
Baseline
COMPLETED
|
3
|
2
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Immediately Post Phase 1 Intervention
STARTED
|
3
|
2
|
|
Immediately Post Phase 1 Intervention
COMPLETED
|
3
|
2
|
|
Immediately Post Phase 1 Intervention
NOT COMPLETED
|
0
|
0
|
|
8 Weeks Post Phase 1 Intervention
STARTED
|
3
|
2
|
|
8 Weeks Post Phase 1 Intervention
COMPLETED
|
3
|
2
|
|
8 Weeks Post Phase 1 Intervention
NOT COMPLETED
|
0
|
0
|
|
Immediately Post Phase 2 Intervention
STARTED
|
3
|
2
|
|
Immediately Post Phase 2 Intervention
COMPLETED
|
2
|
2
|
|
Immediately Post Phase 2 Intervention
NOT COMPLETED
|
1
|
0
|
|
8 Weeks Post Phase 2 Intervention
STARTED
|
2
|
2
|
|
8 Weeks Post Phase 2 Intervention
COMPLETED
|
2
|
2
|
|
8 Weeks Post Phase 2 Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)
Baseline characteristics by cohort
| Measure |
Active to Sham Transcranial Direct Current Stimulation
n=3 Participants
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
|
Sham to Active Transcranial Direct Current Stimulation
n=2 Participants
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 24.6 • n=13 Participants
|
50 years
STANDARD_DEVIATION 15.6 • n=15 Participants
|
48.6 years
STANDARD_DEVIATION 19.1 • n=28 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
|
The Controlled Oral Word Association Test
|
30.67 items
STANDARD_DEVIATION 7.23 • n=13 Participants
|
30.5 items
STANDARD_DEVIATION 0.71 • n=15 Participants
|
30.6 items
STANDARD_DEVIATION 5.13 • n=28 Participants
|
|
Category Fluency
|
18 Total items
STANDARD_DEVIATION 1.73 • n=13 Participants
|
17 Total items
STANDARD_DEVIATION 0 • n=15 Participants
|
17.6 Total items
STANDARD_DEVIATION 1.34 • n=28 Participants
|
|
The Boston Naming Test
|
26.67 Total items
STANDARD_DEVIATION 2.52 • n=13 Participants
|
28 Total items
STANDARD_DEVIATION 0 • n=15 Participants
|
27.2 Total items
STANDARD_DEVIATION 1.93 • n=28 Participants
|
|
Semantic Object Retrieval Test
|
30.33 Total items
STANDARD_DEVIATION 1.53 • n=13 Participants
|
30.5 Total items
STANDARD_DEVIATION 2.12 • n=15 Participants
|
30.4 Total items
STANDARD_DEVIATION 1.52 • n=28 Participants
|
|
The Delis Kaplan Color Word Interference Test, naming
|
35.66666667 Time- Seconds
STANDARD_DEVIATION 5.131601439 • n=13 Participants
|
41 Time- Seconds
STANDARD_DEVIATION 7.071067812 • n=15 Participants
|
37.8 Time- Seconds
STANDARD_DEVIATION 5.85 • n=28 Participants
|
|
The Delis Kaplan Color Word Interference Test, reading
|
26 Time - seconds
STANDARD_DEVIATION 6.244997998 • n=13 Participants
|
27.5 Time - seconds
STANDARD_DEVIATION 12.02081528 • n=15 Participants
|
26.6 Time - seconds
STANDARD_DEVIATION 7.503332593 • n=28 Participants
|
|
The Delis Kaplan Color Word Interference Test, inhibition
|
57 Time - seconds
STANDARD_DEVIATION 5 • n=13 Participants
|
71.5 Time - seconds
STANDARD_DEVIATION 9.192388155 • n=15 Participants
|
62.8 Time - seconds
STANDARD_DEVIATION 9.833615815 • n=28 Participants
|
|
The Delis Kaplan Color Word Interference Test, inhibition and switching
|
71.33333333 Time - seconds
STANDARD_DEVIATION 19.85782801 • n=13 Participants
|
75 Time - seconds
STANDARD_DEVIATION 16.97056275 • n=15 Participants
|
72.8 Time - seconds
STANDARD_DEVIATION 16.52876281 • n=28 Participants
|
|
Rey Auditory Verbal Learning Test and alternative lists, total learning
|
40.66666667 Total items
STANDARD_DEVIATION 15.14375559 • n=13 Participants
|
48.5 Total items
STANDARD_DEVIATION 3.535533906 • n=15 Participants
|
43.8 Total items
STANDARD_DEVIATION 11.67047557 • n=28 Participants
|
|
Rey Auditory Verbal Learning Test and alternative lists, delayed recall
|
7.333333333 Total items
STANDARD_DEVIATION 5.033222957 • n=13 Participants
|
9.5 Total items
STANDARD_DEVIATION 0.707106781 • n=15 Participants
|
8.2 Total items
STANDARD_DEVIATION 3.768288736 • n=28 Participants
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2.
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Controlled Oral Word Association Test
Baseline
|
30.67 Total items
Standard Deviation 7.23
|
30.5 Total items
Standard Deviation 0.71
|
|
The Controlled Oral Word Association Test
Immediate post completion of phase 1 intervention
|
33.33 Total items
Standard Deviation 5.69
|
35 Total items
Standard Deviation 0
|
|
The Controlled Oral Word Association Test
8 weeks post completion of phase 1 intervention
|
34.67 Total items
Standard Deviation 7.51
|
39.5 Total items
Standard Deviation 7.78
|
|
The Controlled Oral Word Association Test
Immediate post completion of phase 2 intervention
|
31 Total items
Standard Deviation 9.9
|
48.5 Total items
Standard Deviation 3.54
|
|
The Controlled Oral Word Association Test
8 weeks post completion of phase 2 intervention
|
33.5 Total items
Standard Deviation 4.95
|
43.5 Total items
Standard Deviation 4.95
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2.
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Category Fluency
Baseline
|
18 Total items
Standard Deviation 1.73
|
17 Total items
Standard Deviation 0
|
|
Category Fluency
Immediate post completion of phase 1 intervention
|
17.67 Total items
Standard Deviation 6.35
|
24.5 Total items
Standard Deviation 0.71
|
|
Category Fluency
8 weeks post completion of phase 1 intervention
|
20 Total items
Standard Deviation 2.65
|
22.5 Total items
Standard Deviation 0.71
|
|
Category Fluency
Immediate post completion of phase 2 intervention
|
11 Total items
Standard Deviation 1.41
|
27.5 Total items
Standard Deviation 3.54
|
|
Category Fluency
8 weeks post completion of phase 2 intervention
|
17.5 Total items
Standard Deviation 2.12
|
20.5 Total items
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Boston Naming Test
Immediate post completion of phase 2 intervention
|
27 Total items
Standard Deviation 1.41
|
30 Total items
Standard Deviation NA
Only one subject
|
|
The Boston Naming Test
8 weeks post completion of phase 2 intervention
|
28 Total items
Standard Deviation 2.83
|
30 Total items
Standard Deviation 0
|
|
The Boston Naming Test
Baseline
|
26.67 Total items
Standard Deviation 2.52
|
28 Total items
Standard Deviation 0
|
|
The Boston Naming Test
Immediate post completion of phase 1 intervention
|
27 Total items
Standard Deviation 1
|
29.5 Total items
Standard Deviation 0.71
|
|
The Boston Naming Test
8 weeks post completion of phase 1 intervention
|
27.33 Total items
Standard Deviation 1.53
|
28.5 Total items
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Semantic Object Retrieval Test
Baseline
|
30.33 Total items
Standard Deviation 1.53
|
30.5 Total items
Standard Deviation 2.12
|
|
Semantic Object Retrieval Test
8 weeks post completion of phase 2 intervention
|
32 Total items
Standard Deviation 0
|
31.5 Total items
Standard Deviation 0.71
|
|
Semantic Object Retrieval Test
Immediate post completion of phase 1 intervention
|
31.33 Total items
Standard Deviation 1.15
|
31.5 Total items
Standard Deviation 0.71
|
|
Semantic Object Retrieval Test
8 weeks post completion of phase 1 intervention
|
30.67 Total items
Standard Deviation 1.15
|
31 Total items
Standard Deviation 1.41
|
|
Semantic Object Retrieval Test
Immediate post completion of phase 2 intervention
|
30 Total items
Standard Deviation 1.41
|
31 Total items
Standard Deviation NA
Only one subject
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Naming
8 weeks post completion of phase 1 intervention
|
31.66666667 Time - seconds
Standard Deviation 4.509249753
|
34.5 Time - seconds
Standard Deviation 7.778174593
|
|
The Delis Kaplan Color Word Interference Test, Naming
Baseline
|
35.66666667 Time - seconds
Standard Deviation 5.131601439
|
41 Time - seconds
Standard Deviation 7.071067812
|
|
The Delis Kaplan Color Word Interference Test, Naming
Immediate post completion of phase 1 intervention
|
32.66666667 Time - seconds
Standard Deviation 2.516611478
|
31 Time - seconds
Standard Deviation 8.485281374
|
|
The Delis Kaplan Color Word Interference Test, Naming
Immediate post completion of phase 2 intervention
|
34.5 Time - seconds
Standard Deviation 3.535533906
|
32 Time - seconds
Standard Deviation NA
Only one subject
|
|
The Delis Kaplan Color Word Interference Test, Naming
8 weeks post completion of phase 2 intervention
|
29 Time - seconds
Standard Deviation 5.656854249
|
34.5 Time - seconds
Standard Deviation 3.535533906
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Reading
Baseline
|
26 Time - seconds
Standard Deviation 6.244997998
|
27.5 Time - seconds
Standard Deviation 12.02081528
|
|
The Delis Kaplan Color Word Interference Test, Reading
Immediate post completion of phase 1 intervention
|
24 Time - seconds
Standard Deviation 7
|
24 Time - seconds
Standard Deviation 4.242640687
|
|
The Delis Kaplan Color Word Interference Test, Reading
8 weeks post completion of phase 1 intervention
|
25.66666667 Time - seconds
Standard Deviation 6.658328118
|
25.5 Time - seconds
Standard Deviation 7.778174593
|
|
The Delis Kaplan Color Word Interference Test, Reading
Immediate post completion of phase 2 intervention
|
31.5 Time - seconds
Standard Deviation 3.535533906
|
27 Time - seconds
Standard Deviation NA
Only one subject
|
|
The Delis Kaplan Color Word Interference Test, Reading
8 weeks post completion of phase 2 intervention
|
24.5 Time - seconds
Standard Deviation 0.707106781
|
27 Time - seconds
Standard Deviation 4.242640687
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Inhibition
Baseline
|
57 Time - seconds
Standard Deviation 5
|
71.5 Time - seconds
Standard Deviation 9.192388155
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
Immediate post completion of phase 1 intervention
|
46 Time - seconds
Standard Deviation 2.645751311
|
64 Time - seconds
Standard Deviation 9.899494937
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
8 weeks post completion of phase 1 intervention
|
53 Time - seconds
Standard Deviation 3.464101615
|
58.5 Time - seconds
Standard Deviation 9.192388155
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
Immediate post completion of phase 2 intervention
|
48 Time - seconds
Standard Deviation 5.656854249
|
66 Time - seconds
Standard Deviation NA
Only one subject
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
8 weeks post completion of phase 2 intervention
|
46.5 Time - seconds
Standard Deviation 0.707106781
|
59.5 Time - seconds
Standard Deviation 2.121320344
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
8 weeks post completion of phase 2 intervention
|
70 Time - seconds
Standard Deviation 9.899494937
|
52 Time - seconds
Standard Deviation 0
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
Baseline
|
71.33333333 Time - seconds
Standard Deviation 19.85782801
|
75 Time - seconds
Standard Deviation 16.97056275
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
Immediate post completion of phase 1 intervention
|
72 Time - seconds
Standard Deviation 29.13760457
|
58 Time - seconds
Standard Deviation 8.485281374
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
8 weeks post completion of phase 1 intervention
|
75.33333333 Time - seconds
Standard Deviation 24.19366308
|
56.5 Time - seconds
Standard Deviation 6.363961031
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
Immediate post completion of phase 2 intervention
|
61.5 Time - seconds
Standard Deviation 3.535533906
|
53 Time - seconds
Standard Deviation NA
Only one subject
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
Baseline
|
40.66666667 Total items
Standard Deviation 15.14375559
|
48.5 Total items
Standard Deviation 3.535533906
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
Immediate post completion of phase 1 intervention
|
39.33333333 Total items
Standard Deviation 11.8462371
|
57 Total items
Standard Deviation 7.071067812
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
8 weeks post completion of phase 1 intervention
|
43.66666667 Total items
Standard Deviation 11.59022577
|
58 Total items
Standard Deviation 4.242640687
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
Immediate post completion of phase 2 intervention
|
40.5 Total items
Standard Deviation 17.67766953
|
73 Total items
Standard Deviation NA
Only one subject
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
8 weeks post completion of phase 2 intervention
|
38.5 Total items
Standard Deviation 3.535533906
|
63 Total items
Standard Deviation 7.071067812
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
Baseline
|
7.333333333 Total items
Standard Deviation 5.033222957
|
9.5 Total items
Standard Deviation 0.707106781
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
Immediate post completion of phase 1 intervention
|
6 Total items
Standard Deviation 4.582575695
|
12 Total items
Standard Deviation 1.414213562
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
8 weeks post completion of phase 1 intervention
|
8.666666667 Total items
Standard Deviation 4.509249753
|
13.5 Total items
Standard Deviation 2.121320344
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
Immediate post completion of phase 2 intervention
|
7.5 Total items
Standard Deviation 6.363961031
|
15 Total items
Standard Deviation NA
Only one subject
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
8 weeks post completion of phase 2 intervention
|
7 Total items
Standard Deviation 1.414213562
|
11.5 Total items
Standard Deviation 3.535533906
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Trail Making Test - Part A
Immediate post completion of phase 1 intervention
|
27.66666667 Time - seconds
Standard Deviation 11.93035345
|
26.5 Time - seconds
Standard Deviation 13.43502884
|
|
The Trail Making Test - Part A
8 weeks post completion of phase 1 intervention
|
28 Time - seconds
Standard Deviation 19.28730152
|
27 Time - seconds
Standard Deviation 5.656854249
|
|
The Trail Making Test - Part A
Immediate post completion of phase 2 intervention
|
30.5 Time - seconds
Standard Deviation 14.8492424
|
29 Time - seconds
Standard Deviation NA
Only one subject
|
|
The Trail Making Test - Part A
8 weeks post completion of phase 2 intervention
|
34.5 Time - seconds
Standard Deviation 26.1629509
|
26.5 Time - seconds
Standard Deviation 9.192388155
|
|
The Trail Making Test - Part A
Baseline
|
37.66666667 Time - seconds
Standard Deviation 14.36430762
|
41.5 Time - seconds
Standard Deviation 7.778174593
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Trail Making Test - Part B
8 weeks post completion of phase 2 intervention
|
58 Time - seconds
Standard Deviation 15.55634919
|
71.5 Time - seconds
Standard Deviation 7.778174593
|
|
The Trail Making Test - Part B
Baseline
|
68.66666667 Time - seconds
Standard Deviation 21.57158625
|
101 Time - seconds
Standard Deviation 9.899494937
|
|
The Trail Making Test - Part B
Immediate post completion of phase 1 intervention
|
63.66666667 Time - seconds
Standard Deviation 3.511884584
|
52.5 Time - seconds
Standard Deviation 16.26345597
|
|
The Trail Making Test - Part B
8 weeks post completion of phase 1 intervention
|
57.66666667 Time - seconds
Standard Deviation 21.22105872
|
63.5 Time - seconds
Standard Deviation 7.778174593
|
|
The Trail Making Test - Part B
Immediate post completion of phase 2 intervention
|
61.5 Time - seconds
Standard Deviation 10.60660172
|
62 Time - seconds
Standard Deviation NA
Only one subject
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a forward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Digit Span Forward
Baseline
|
0.933333333 Units on Z scale
Standard Deviation 1.078579312
|
0.4 Units on Z scale
Standard Deviation 0.707106781
|
|
Digit Span Forward
Immediate post completion of phase 1 intervention
|
0.3 Units on Z scale
Standard Deviation 0.556776436
|
-0.085 Units on Z scale
Standard Deviation 0.021213203
|
|
Digit Span Forward
8 weeks post completion of phase 1 intervention
|
-0.34 Units on Z scale
Standard Deviation 0.819023809
|
-0.1 Units on Z scale
Standard Deviation 0
|
|
Digit Span Forward
Immediate post completion of phase 2 intervention
|
0.05 Units on Z scale
Standard Deviation 0.494974747
|
-1.05 Units on Z scale
Standard Deviation NA
Only one subject
|
|
Digit Span Forward
8 weeks post completion of phase 2 intervention
|
-0.85 Units on Z scale
Standard Deviation 0.777817459
|
-0.575 Units on Z scale
Standard Deviation 0.671751442
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Digit Span Backward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a backward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Digit Span Backward
Baseline
|
0.2 Units on Z scale
Standard Deviation 1.252996409
|
0.7 Units on Z scale
Standard Deviation 1.272792206
|
|
Digit Span Backward
Immediate post completion of phase 1 intervention
|
-0.933333333 Units on Z scale
Standard Deviation 0.56862407
|
1.525 Units on Z scale
Standard Deviation 0.035355339
|
|
Digit Span Backward
8 weeks post completion of phase 1 intervention
|
0.44 Units on Z scale
Standard Deviation 0.991362699
|
0.25 Units on Z scale
Standard Deviation 0.636396103
|
|
Digit Span Backward
Immediate post completion of phase 2 intervention
|
0.81 Units on Z scale
Standard Deviation 1.965756852
|
-0.19 Units on Z scale
Standard Deviation NA
Only one subject
|
|
Digit Span Backward
8 weeks post completion of phase 2 intervention
|
0.385 Units on Z scale
Standard Deviation 2.566797616
|
0.68 Units on Z scale
Standard Deviation 0.028284271
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score. Total Range 0 (minimum) - 36 (maximum). This is a summed score of the number and accuracy of complex figure features captured. Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
Baseline
|
15.16666667 Score on a scale
Standard Deviation 0.577350269
|
25.5 Score on a scale
Standard Deviation 2.121320344
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
Immediate post completion of phase 1 intervention
|
18.5 Score on a scale
Standard Deviation 3.905124838
|
28 Score on a scale
Standard Deviation 9.899494937
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
8 weeks post completion of phase 1 intervention
|
18 Score on a scale
Standard Deviation 5.408326913
|
32.5 Score on a scale
Standard Deviation 0.707106781
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
Immediate post completion of phase 2 intervention
|
14 Score on a scale
Standard Deviation 9.899494937
|
31 Score on a scale
Standard Deviation NA
Only one subject
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
8 weeks post completion of phase 2 intervention
|
24 Score on a scale
Standard Deviation 11.3137085
|
25.45 Score on a scale
Standard Deviation 3.606244584
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
The Digit Symbol Substitution Test
Baseline
|
45 Total items
Standard Deviation 5.196152423
|
45.5 Total items
Standard Deviation 14.8492424
|
|
The Digit Symbol Substitution Test
Immediate post completion of phase 1 intervention
|
45.33333333 Total items
Standard Deviation 2.516611478
|
58 Total items
Standard Deviation 11.3137085
|
|
The Digit Symbol Substitution Test
8 weeks post completion of phase 1 intervention
|
47.66666667 Total items
Standard Deviation 1.527525232
|
58.5 Total items
Standard Deviation 23.33452378
|
|
The Digit Symbol Substitution Test
Immediate post completion of phase 2 intervention
|
50 Total items
Standard Deviation 4.242640687
|
53 Total items
Standard Deviation NA
Only one subject
|
|
The Digit Symbol Substitution Test
8 weeks post completion of phase 2 intervention
|
48 Total items
Standard Deviation 4.242640687
|
62.5 Total items
Standard Deviation 9.192388155
|
Adverse Events
Active to Sham Transcranial Direct Current Stimulation
Sham to Active Transcranial Direct Current Stimulation
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