Trial Outcomes & Findings for Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury (NCT NCT02613936)
NCT ID: NCT02613936
Last Updated: 2023-10-06
Results Overview
The NIH Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) assesses executive function in four different domains, creating a composite score from all domains, ranging from -3.0 to 2.0 with higher scores indicating better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
1 month
Results posted on
2023-10-06
Participant Flow
Study enrollment was concluded at 40 based on termination of funding.
Participant milestones
| Measure |
Active Anodal tDCS + Cognitive Training
In this arm, patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Anodal tDCS: Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
Placebo Anodal tDCS + Cognitive Training
In this arm, patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Anodal tDCS + Cognitive Training
n=17 Participants
In this arm, 40 patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Anodal tDCS: Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
Placebo Anodal tDCS + Cognitive Training
n=17 Participants
In this arm, 40 patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
34 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=34 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 12.3 • n=17 Participants
|
35.8 years
STANDARD_DEVIATION 13.6 • n=17 Participants
|
34.8 years
STANDARD_DEVIATION 13.0 • n=34 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=17 Participants
|
7 Participants
n=17 Participants
|
16 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=17 Participants
|
10 Participants
n=17 Participants
|
18 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 monthThe NIH Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) assesses executive function in four different domains, creating a composite score from all domains, ranging from -3.0 to 2.0 with higher scores indicating better outcome.
Outcome measures
| Measure |
Active Anodal tDCS + Cognitive Training
n=17 Participants
In this arm, patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Anodal tDCS: Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
Placebo Anodal tDCS + Cognitive Training
n=17 Participants
In this arm, patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
|---|---|---|
|
Examiner Score
Baseline
|
0.617 score on a scale
Standard Deviation 0.677
|
0.907 score on a scale
Standard Deviation 0.659
|
|
Examiner Score
End of Treatment
|
0.865 score on a scale
Standard Deviation 0.677
|
1.155 score on a scale
Standard Deviation 0.669
|
|
Examiner Score
1 month Visit
|
1.037 score on a scale
Standard Deviation 0.677
|
1.26 score on a scale
Standard Deviation 0.659
|
Adverse Events
Active Anodal tDCS + Cognitive Training
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Anodal tDCS + 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 Anodal tDCS + Cognitive Training
n=17 participants at risk
In this arm, 40 patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Anodal tDCS: Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
Placebo Anodal tDCS + Cognitive Training
n=17 participants at risk
In this arm, 40 patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
Cognitive training: Cognitive training involves solving executive function tasks on a computer.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
17.6%
3/17 • Number of events 3 • 1 month
|
0.00%
0/17 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place