Trial Outcomes & Findings for Remediation of Auditory Recognition in Schizophrenia With tDCS (NCT NCT02869334)
NCT ID: NCT02869334
Last Updated: 2021-07-08
Results Overview
Ability to match tones following brief delay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change in performance from Baseline at completion of training (week 16)
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Auditory Remediation With Active tDCS
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remediation of Auditory Recognition in Schizophrenia With tDCS
Baseline characteristics by cohort
| Measure |
Auditory Remediation With Active tDCS
n=2 Participants
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=3 Participants
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
44.7 years
STANDARD_DEVIATION 14.4 • n=107 Participants
|
42.4 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Tone matching (i.e. ability to match tones following brief delay)
|
53.6 percent correct
STANDARD_DEVIATION 5.1 • n=99 Participants
|
54.3 percent correct
STANDARD_DEVIATION 12.7 • n=107 Participants
|
54.0 percent correct
STANDARD_DEVIATION 9.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: Change in performance from Baseline at completion of training (week 16)Population: completers
Ability to match tones following brief delay
Outcome measures
| Measure |
Auditory Remediation With Active tDCS
n=2 Participants
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=3 Participants
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
Auditory Tone Matching Task
|
-4.3 %correct, different trials
Standard Deviation 12.1
|
4.8 %correct, different trials
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Change in performance from Baseline at completion of training (week 16)Ability to detect emotion based on tone of voice
Outcome measures
| Measure |
Auditory Remediation With Active tDCS
n=2 Participants
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=3 Participants
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
Auditory Emotion Recognition (AER) Task
|
-3.0 %correct
Standard Deviation 8.6
|
5.1 %correct
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Change in performance from Baseline at completion of training (week 16)Penn Emotion Recognition Test-40 Faces Version
Outcome measures
| Measure |
Auditory Remediation With Active tDCS
n=2 Participants
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=2 Participants
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
ER-40
|
-5.0 percent correct
Standard Deviation 3.5
|
-1.3 percent correct
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Change in performance from Baseline at completion of training (week 16)The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better.
Outcome measures
| Measure |
Auditory Remediation With Active tDCS
n=2 Participants
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=3 Participants
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
The Awareness of Social Inference Test (TASIT)
|
10 score on a scale
Standard Deviation 4.2
|
0 score on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Change in performance from Baseline at completion of training (week 16)Population: Subjects who completed post-testing and had usable data
Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)
Outcome measures
| Measure |
Auditory Remediation With Active tDCS
n=1 Participants
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=2 Participants
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
Auditory Mismatch Negativity (MMN)
|
-1.47 microvolt
Standard Deviation 0
|
-.98 microvolt
Standard Deviation 1.07
|
Adverse Events
Auditory Remediation With Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Auditory Remediation With Sham tDCS
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 |
Auditory Remediation With Active tDCS
n=2 participants at risk
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
Auditory Remediation With Sham tDCS
n=3 participants at risk
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS
Auditory Remediation: Computer program designed to improve discrimination between sounds
|
|---|---|---|
|
Nervous system disorders
sedation
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
0.00%
0/3 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place