Trial Outcomes & Findings for Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations (NCT NCT02769507)
NCT ID: NCT02769507
Last Updated: 2026-05-19
Results Overview
Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Change from Baseline to immediately after treatment and 3 months after treatment
Results posted on
2026-05-19
Participant Flow
Participant milestones
| Measure |
Real tDCS
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Real tDCS
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Overall Study
Participants found particiption too challenging
|
2
|
1
|
Baseline Characteristics
Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Baseline characteristics by cohort
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=10 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Age, Continuous
|
38 years
n=30 Participants
|
33 years
n=30 Participants
|
36 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
21 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentSelf-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations
Outcome measures
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=9 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Auditory Hallucination Rating Scale (AHRS)
Immediately after treatment
|
26.82 AHRS total score
Standard Deviation 8.159
|
20.89 AHRS total score
Standard Deviation 7.219
|
|
Auditory Hallucination Rating Scale (AHRS)
3 month follow-up
|
23.55 AHRS total score
Standard Deviation 7.271
|
21.56 AHRS total score
Standard Deviation 5.703
|
|
Auditory Hallucination Rating Scale (AHRS)
Before treatment
|
30.00 AHRS total score
Standard Deviation 4.980
|
24.33 AHRS total score
Standard Deviation 4.183
|
PRIMARY outcome
Timeframe: Change from Baseline to immediately after treatmentMeasure for changes in severity of auditory hallucinations; participants rated in percent how much their symptoms had improved (or worsened). The range is thus -100 (symptoms reduced by 100%) to +100 (symptoms worsened by 100%)
Outcome measures
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=9 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Hallucination Change Scale (HCS)
|
-24.9 percentage
Standard Deviation 34
|
-21.7 percentage
Standard Deviation 28
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentPositive Sum Score; conducted by clinical rater; consists of 10 items, range 7-49; higher scores indicate more severe symptoms
Outcome measures
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=10 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Before treatment
|
18.45 Positive sum score
Standard Deviation 6.393
|
19.20 Positive sum score
Standard Deviation 4.962
|
|
Positive and Negative Syndrome Scale (PANSS)
Immediately after treatment
|
17.82 Positive sum score
Standard Deviation 5.879
|
14.70 Positive sum score
Standard Deviation 9.476
|
|
Positive and Negative Syndrome Scale (PANSS)
3 month follow-up
|
18.36 Positive sum score
Standard Deviation 6.439
|
17.60 Positive sum score
Standard Deviation 5.777
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentMeasure of executive functioning, Stroop condition #3 in seconds; higher values indicate longer task duration and worse performance
Outcome measures
| Measure |
Real tDCS
n=7 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=7 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Stroop Task
Before treatment
|
73 seconds
Standard Deviation 22
|
77 seconds
Standard Deviation 21
|
|
Stroop Task
Immediately after treatment
|
66 seconds
Standard Deviation 12
|
63 seconds
Standard Deviation 11
|
|
Stroop Task
3 month follow-up
|
80 seconds
Standard Deviation 25
|
69 seconds
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentMeasure of visuomotor speed
Outcome measures
| Measure |
Real tDCS
n=7 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=7 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Trailmaking Test B
Before treatment
|
133 seconds
Standard Deviation 41
|
93 seconds
Standard Deviation 48
|
|
Trailmaking Test B
Immediately after treatment
|
110 seconds
Standard Deviation 53
|
82 seconds
Standard Deviation 36
|
|
Trailmaking Test B
3 month follow-up
|
153 seconds
Standard Deviation 141
|
86 seconds
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Before, immediately after treatment, and at 3 month follow-upTotal sum of AES score; consists of 18 items; range 18-72, higher values indicate higher degree of apathy
Outcome measures
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=9 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Apathy Evaluation Scale
Before treatment
|
47.55 score on a scale
Standard Deviation 8.560
|
46.11 score on a scale
Standard Deviation 11.805
|
|
Apathy Evaluation Scale
Immediately after treatment
|
51.82 score on a scale
Standard Deviation 8.400
|
40.56 score on a scale
Standard Deviation 19.372
|
|
Apathy Evaluation Scale
3 month follow-up
|
52.45 score on a scale
Standard Deviation 11.544
|
47.56 score on a scale
Standard Deviation 8.876
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentMeasure of global functioning; rated by clinician on a 7-point scale, with the severity of illness scale rated from 1 (normal) through to 7 (most severely ill)
Outcome measures
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=9 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
The Clinical Global Impressions Scale - Severity
Before treatment
|
4.91 score on a scale
Standard Deviation 0.831
|
4.56 score on a scale
Standard Deviation 0.527
|
|
The Clinical Global Impressions Scale - Severity
Immediately after treatment
|
5.00 score on a scale
Standard Deviation 0.632
|
4.44 score on a scale
Standard Deviation 0.726
|
|
The Clinical Global Impressions Scale - Severity
3 month follow-up
|
4.91 score on a scale
Standard Deviation 0.701
|
4.44 score on a scale
Standard Deviation 1.130
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentMeasure of global functioning - Symptoms, rated by clinician; measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100, where 0 is severely impacted in daily life by symptoms and 100 is not affected at all
Outcome measures
| Measure |
Real tDCS
n=11 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=9 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Global Assessment of Functioning - S
Before treatment
|
43.27 score on a scale
Standard Deviation 12.618
|
46.22 score on a scale
Standard Deviation 8.541
|
|
Global Assessment of Functioning - S
Immediately after treatment
|
42.91 score on a scale
Standard Deviation 11.691
|
45.44 score on a scale
Standard Deviation 9.382
|
|
Global Assessment of Functioning - S
3 month follow-up
|
42.55 score on a scale
Standard Deviation 12.201
|
44.00 score on a scale
Standard Deviation 11.079
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentMeasure of executive functioning, forced left condition, percentage reported from left ear
Outcome measures
| Measure |
Real tDCS
n=9 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=8 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Dichotic Listening Paradigm
Before treatment
|
19.63 percentage correct left ear reports
Standard Deviation 15.32
|
25.83 percentage correct left ear reports
Standard Deviation 22.52
|
|
Dichotic Listening Paradigm
Immediately after treatment
|
20.37 percentage correct left ear reports
Standard Deviation 18.89
|
22.5 percentage correct left ear reports
Standard Deviation 19.74
|
|
Dichotic Listening Paradigm
3 month follow-up
|
16.67 percentage correct left ear reports
Standard Deviation 19.41
|
22.5 percentage correct left ear reports
Standard Deviation 20.76
|
SECONDARY outcome
Timeframe: Change from Baseline to immediately after treatment and 3 months after treatmentMeasure of language lateralization, laterality index in non-forced condition, laterality index is computed according to formula: LI=\[(R-L)/(R+L)\]\*100, where "L" and "R" are the number of correct left and right ear responses, respectively. values can range between -100 (only syllables from left ear correctly reported and +100 (only correct syllables from right ear reported)
Outcome measures
| Measure |
Real tDCS
n=6 Participants
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=5 Participants
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Dichotic Listening Laterality Index
Before treatment
|
-14.66 laterality index, non-forced condition
Standard Deviation 33.75
|
-0.45 laterality index, non-forced condition
Standard Deviation 7.89
|
|
Dichotic Listening Laterality Index
Immediately after treatment
|
-1.45 laterality index, non-forced condition
Standard Deviation 40.93
|
9.15 laterality index, non-forced condition
Standard Deviation 20.79
|
|
Dichotic Listening Laterality Index
3 month follow-up
|
22.86 laterality index, non-forced condition
Standard Deviation 14.73
|
7.58 laterality index, non-forced condition
Standard Deviation 28.86
|
Adverse Events
Real tDCS
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Real tDCS
n=13 participants at risk
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
DC Stimulator PLUS (NeuroConn)
|
Sham tDCS
n=11 participants at risk
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
DC Stimulator PLUS (NeuroConn)
|
|---|---|---|
|
Psychiatric disorders
Participant stopped treatment
|
15.4%
2/13 • Number of events 2 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
9.1%
1/11 • Number of events 1 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
Headache
|
23.1%
3/13 • Number of events 8 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
36.4%
4/11 • Number of events 17 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
neck pain
|
7.7%
1/13 • Number of events 1 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
45.5%
5/11 • Number of events 25 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
scalp pain
|
23.1%
3/13 • Number of events 14 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
27.3%
3/11 • Number of events 14 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
tingling
|
76.9%
10/13 • Number of events 67 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
63.6%
7/11 • Number of events 30 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
itching
|
69.2%
9/13 • Number of events 39 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
45.5%
5/11 • Number of events 24 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
burning sensation
|
30.8%
4/13 • Number of events 38 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
63.6%
7/11 • Number of events 38 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
skin redness
|
53.8%
7/13 • Number of events 40 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
9.1%
1/11 • Number of events 2 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
sleepiness
|
38.5%
5/13 • Number of events 20 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
63.6%
7/11 • Number of events 28 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
trouble concentrating
|
23.1%
3/13 • Number of events 26 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
36.4%
4/11 • Number of events 13 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
|
General disorders
acute mood change
|
15.4%
2/13 • Number of events 3 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
18.2%
2/11 • Number of events 12 • 3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., \& Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place