Trial Outcomes & Findings for Circuitry Assessment and Reinforcement Training Effects on Recovery (NCT NCT04290988)
NCT ID: NCT04290988
Last Updated: 2026-02-05
Results Overview
Change in number of items correctly named on a behavioral picture naming assessment. The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline, 1 week following each intervention period
Results posted on
2026-02-05
Participant Flow
7 participants were enrolled. 1 participant withdrew before randomization.
Participant milestones
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Circuitry Assessment and Reinforcement Training Effects on Recovery
Baseline characteristics by cohort
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 27.3 • n=41 Participants
|
80 years
STANDARD_DEVIATION 3.5 • n=1581 Participants
|
67.3 years
STANDARD_DEVIATION 22.6 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Philadelphia Naming Test
|
59 score on a scale
STANDARD_DEVIATION 49.4 • n=41 Participants
|
85 score on a scale
STANDARD_DEVIATION 74.7 • n=1581 Participants
|
72 score on a scale
STANDARD_DEVIATION 58.4 • n=4626 Participants
|
|
Controlled Oral Word Association (COWA)
|
4 score on a scale
STANDARD_DEVIATION 4.6 • n=41 Participants
|
7.5 score on a scale
STANDARD_DEVIATION 10.6 • n=1581 Participants
|
5.4 score on a scale
STANDARD_DEVIATION 6.5 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 week following each intervention periodChange in number of items correctly named on a behavioral picture naming assessment. The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability)
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Number of Items Correctly Named on the Philadelphia Naming Test
Difference Post Phase 1
|
6.7 Number of Items Correct on Naming Test
Standard Deviation 10.7
|
2.3 Number of Items Correct on Naming Test
Standard Deviation 4.9
|
|
Change in Number of Items Correctly Named on the Philadelphia Naming Test
Difference Post Phase 2
|
-12 Number of Items Correct on Naming Test
Standard Deviation 10.5
|
-5 Number of Items Correct on Naming Test
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodThis is a measure of attention, executive function, and word-retrieval. COWA scores range from 0 to infinity. Lower scores represent more language impairment.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Controlled Oral Word Association Test (COWA) Score
Post Phase 1
|
6 Number of Correct Items on COWA Test
Standard Deviation 7.2
|
8 Number of Correct Items on COWA Test
Standard Deviation 11.3
|
|
Change in Controlled Oral Word Association Test (COWA) Score
Post Phase 2
|
3.7 Number of Correct Items on COWA Test
Standard Deviation 4.0
|
7.5 Number of Correct Items on COWA Test
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention period and 8 weeks following both intervention periodsChange in quality of sleep measured with The Pittsburgh Sleep Quality Index (PSQI). This has 7 items with each item scored from 0 to 3. Overall score ranges from 0 to 21 with higher scores representing poor sleep quality.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Quality of Sleep as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Difference Post Phase 1
|
0.67 Score on Pittsburgh Sleep Quality Index
Standard Deviation 7.57
|
5.67 Score on Pittsburgh Sleep Quality Index
Standard Deviation 5.51
|
|
Change in Quality of Sleep as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Difference Post Phase 2
|
-0.33 Score on Pittsburgh Sleep Quality Index
Standard Deviation 2.89
|
-3.33 Score on Pittsburgh Sleep Quality Index
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention period and 8 weeks following both intervention periodsPopulation: Participants with data collected. One participant in each group was unable to complete this self-reported index due to the severity of their language deficits related to their aphasia prohibiting them from completing the questionnaire items.
Change in anxiety measured with State Trait Anxiety Inventory. This is a 40-item questionnaire scored on a 4 point likert scale (1-4). Overall score ranges from 40 to 160 with higher scores representing greater (worse) anxiety. STAI Part 1 Score range 20-80 and STAI Part 2 score range 20-80 with higher scores representing greater (worse) anxiety.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=2 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=2 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Anxiety as Assessed by the State Trait Anxiety Inventory (STAI)
Difference Post Phase 1, STAI Part 1
|
10 score on a scale
Standard Deviation 9.9
|
-4.5 score on a scale
Standard Deviation 6.36
|
|
Change in Anxiety as Assessed by the State Trait Anxiety Inventory (STAI)
Difference Post Phase 2, STAI Part 1
|
-7 score on a scale
Standard Deviation 8.49
|
8.5 score on a scale
Standard Deviation 2.12
|
|
Change in Anxiety as Assessed by the State Trait Anxiety Inventory (STAI)
Difference Post Phase 1, STAI Part 2
|
-3.5 score on a scale
Standard Deviation 0.71
|
1 score on a scale
Standard Deviation 7.07
|
|
Change in Anxiety as Assessed by the State Trait Anxiety Inventory (STAI)
Difference Post Phase 2, STAI Part 2
|
-0.5 score on a scale
Standard Deviation 7.78
|
2 score on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodChange in number of doses of sleep medication taken per week
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Sleep Medication Dosage
Difference Post Phase 1
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Change in Sleep Medication Dosage
Difference Post Phase 2
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention period and 8 weeks following both intervention periodsChange in frequency of sleep medication taken per week.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Sleep Medication Frequency
Difference Post Phase 1
|
0 Number of Doses taken per week
Standard Deviation 0
|
0 Number of Doses taken per week
Standard Deviation 0
|
|
Change in Sleep Medication Frequency
Difference Post Phase 2
|
0 Number of Doses taken per week
Standard Deviation 0
|
0 Number of Doses taken per week
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodMeasurement of brainwave activity (absolute power in microvolts) in each frequency band (alpha, beta, theta, delta, gamma) on Quantitative EEG (qEEG). The difference in average absolute power is combined to report all frequency bands.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Absolute Power on EEG
Difference Post Phase 2
|
-0.49 EEG Absolute Power (microvolts)
Standard Deviation 0.64
|
0.38 EEG Absolute Power (microvolts)
Standard Deviation 0.34
|
|
Change in Absolute Power on EEG
Difference Post Phase 1
|
0.53 EEG Absolute Power (microvolts)
Standard Deviation 0.66
|
0.42 EEG Absolute Power (microvolts)
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodMeasurement of brainwave activity (peak alpha amplitude frequency in hertz) on qEEG.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in Peak Amplitude Frequency on EEG
Difference Post Phase 1
|
0.29 Peak amplitude frequency (Hz)
Standard Deviation 0.72
|
0.24 Peak amplitude frequency (Hz)
Standard Deviation 0.11
|
|
Change in Peak Amplitude Frequency on EEG
Difference Post Phase 2
|
0.72 Peak amplitude frequency (Hz)
Standard Deviation 0.71
|
-0.04 Peak amplitude frequency (Hz)
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodComparison of z-scores for absolute power pre- and post-interventions. A Z-score of 0 represents the population mean. A z-score of \<-2 and \>2 is clinically worse than values approximating the z score central value (0) the population mean.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in EEG Absolute Power Z-scores
Difference Post Phase 1
|
0.53 z score
Standard Deviation 0.29
|
0.23 z score
Standard Deviation 0.44
|
|
Change in EEG Absolute Power Z-scores
Difference Post Phase 2
|
-0.41 z score
Standard Deviation 0.27
|
0.14 z score
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodComparison of z-scores for peak alpha amplitude frequency pre- and post-interventions. A z-score of \<-2 and \>2 is clinically worse than values approximating the z score central value (0) the population mean.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in EEG Peak Amplitude Frequency Z-scores
Difference Post Phase 1
|
0.34 z score
Standard Deviation 0.74
|
0.31 z score
Standard Deviation 0.14
|
|
Change in EEG Peak Amplitude Frequency Z-scores
Difference Post Phase 2
|
0.58 z score
Standard Deviation 0.7
|
-0.07 z score
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline, 1 week following each intervention periodComparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma). A Z-score of 0 represents the population mean. A z-score of \<-2 and \>2 is clinically worse than values approximating the z score central value (0) the population mean. The difference in average z-score is combined to report coherence in all frequency bands.
Outcome measures
| Measure |
Active EEG Neurofeedback, Then Sham Neurofeedback
n=3 Participants
15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
Sham Feedback, Then Active Neurofeedback
n=3 Participants
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks followed by 15 sessions of active neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
|
|---|---|---|
|
Change in EEG Coherence Z-scores
Difference Post Phase 1
|
0.13 z-score
Standard Deviation 0.32
|
-0.11 z-score
Standard Deviation 0.31
|
|
Change in EEG Coherence Z-scores
Difference Post Phase 2
|
-0.04 z-score
Standard Deviation 1.02
|
-0.09 z-score
Standard Deviation 0.4
|
Adverse Events
Active EEG Neurofeedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Feedback
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