Trial Outcomes & Findings for Improving Hallucinations by Targeting the rSTS With tES (NCT NCT05165654)
NCT ID: NCT05165654
Last Updated: 2025-09-17
Results Overview
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
COMPLETED
NA
12 participants
Change from baseline to day 5
2025-09-17
Participant Flow
Participants were recruited through patient conversations and advertisements.
Individuals performed a full clinical assessment including a structured clinical interview and medical history review to confirm diagnosis. Individuals were required to have a history or current hallucinations (visual, auditory, tactile, etc.) to participate in the study. Participants were then randomized to one of the two arms of the study (active tDCS or sham) targeting the right superior temporal sulcus.
Participant milestones
| Measure |
Active Stimulation With TDCS
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
Baseline
|
6
|
6
|
|
Overall Study
Day 5
|
6
|
6
|
|
Overall Study
1 Month
|
5
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Hallucinations by Targeting the rSTS With tES
Baseline characteristics by cohort
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
37.5 years
STANDARD_DEVIATION 14.8 • n=107 Participants
|
37.1 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 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
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Prior/Current Hallucinations
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to day 5Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
60.5 score on a scale
Interval 47.75 to 77.0
|
60 score on a scale
Interval 53.75 to 69.25
|
|
Positive and Negative Syndrome Scale (PANSS)
Day 5
|
56 score on a scale
Interval 44.25 to 75.25
|
63 score on a scale
Interval 59.0 to 70.0
|
PRIMARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice' R package used for multiple imputation on 1 Month data
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
60.5 score on a scale
Interval 47.75 to 77.0
|
60 score on a scale
Interval 53.75 to 69.25
|
|
Positive and Negative Syndrome Scale (PANSS)
1 Month
|
58.5 score on a scale
Interval 47.0 to 67.75
|
70.5 score on a scale
Interval 60.25 to 83.75
|
PRIMARY outcome
Timeframe: Change from baseline to day 5Population: Total quantitative score reported (min = 0; max = 14)
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Baseline
|
1.85 score on a scale
Interval 1.725 to 2.025
|
1.9 score on a scale
Interval 1.85 to 2.0125
|
|
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Day 5
|
1.3 score on a scale
Interval 1.25 to 1.35
|
2 score on a scale
Interval 1.8 to 2.2
|
PRIMARY outcome
Timeframe: Change from baseline to month follow-upPopulation: Total quantitative score reported (min = 0; max = 14)
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Baseline
|
1.85 score on a scale
Interval 1.725 to 2.025
|
1.9 score on a scale
Interval 1.85 to 2.0125
|
|
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
1 Month
|
1.4 score on a scale
Interval 1.05 to 1.6875
|
2.35 score on a scale
Interval 2.05 to 2.4
|
PRIMARY outcome
Timeframe: Change from baseline to day 5Population: Total score reported (0-41).
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
7-item Auditory Hallucinations Rating Scale (AHRS)
Baseline
|
0 score on a scale
Interval 0.0 to 0.0
|
8 score on a scale
Interval 0.0 to 19.75
|
|
7-item Auditory Hallucinations Rating Scale (AHRS)
Day 5
|
0 score on a scale
Interval 0.0 to 0.0
|
6 score on a scale
Interval 0.0 to 22.5
|
PRIMARY outcome
Timeframe: Change from baseline to month follow-upPopulation: Total score reported (0-41)
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
7-item Auditory Hallucinations Rating Scale (AHRS)
Baseline
|
0 score on a scale
Interval 0.0 to 0.0
|
8 score on a scale
Interval 0.0 to 19.75
|
|
7-item Auditory Hallucinations Rating Scale (AHRS)
1 Month
|
0 score on a scale
Interval 0.0 to 0.0
|
6 score on a scale
Interval 0.0 to 23.25
|
SECONDARY outcome
Timeframe: Change from baseline to day 5Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular auditory frequency of interest.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=5 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Auditory Steady State Evoked Potential
Baseline
|
0.369044853 decibels
Interval 0.091708253 to 0.624277228
|
0.434681797 decibels
Interval 0.16328823 to 0.643059721
|
|
Auditory Steady State Evoked Potential
Day
|
0.259385513 decibels
Interval 0.190658708 to 0.314372544
|
0.257550439 decibels
Interval -0.046862077 to 0.352363789
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 1 individual in the active TDCS group had unusable data due to poor data quality.
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular auditory frequency of interest.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=5 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Auditory Steady State Evoked Potential
Baseline
|
0.369044853 decibels
Interval 0.091708253 to 0.624277228
|
0.434681797 decibels
Interval 0.16328823 to 0.643059721
|
|
Auditory Steady State Evoked Potential
1 Month
|
0.307252913 decibels
Interval 0.241709825 to 0.677070695
|
0.221649958 decibels
Interval -0.021732331 to 0.406676752
|
SECONDARY outcome
Timeframe: Change from baseline to day 5Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual frequency of interest.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=5 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Steady State Visual Evoked Potential
Baseline
|
-0.62131125 decibels
Interval -0.726391384 to -0.074934424
|
-0.046333327 decibels
Interval -0.103732736 to 0.052670088
|
|
Steady State Visual Evoked Potential
Day 5
|
-0.101487523 decibels
Interval -0.548558447 to 0.099856615
|
-0.061733608 decibels
Interval -0.291644849 to 0.143966164
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 1 individual in the active TDCS group had unusable data due to poor data quality.
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual frequency of interest.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=5 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Steady State Visual Evoked Potential
Baseline
|
-0.62131125 decibels
Interval -0.726391384 to -0.074934424
|
-0.046333327 decibels
Interval -0.103732736 to 0.052670088
|
|
Steady State Visual Evoked Potential
1 Month
|
0.276320034 decibels
Interval 0.09372428 to 0.34434154
|
-0.342125912 decibels
Interval -0.525993493 to -0.203782791
|
SECONDARY outcome
Timeframe: Change from baseline to day 5Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual/auditory frequency of interest.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=5 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Cross Modal Steady State Evoked Potential
Baseline
|
-0.129873057 decibels
Interval -0.351085988 to -0.039036888
|
-0.225582699 decibels
Interval -0.369160721 to -0.084290267
|
|
Cross Modal Steady State Evoked Potential
Day 5
|
-0.227227968 decibels
Interval -0.314087578 to -0.209605677
|
-0.309958523 decibels
Interval -0.479995017 to -0.140836317
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 1 individual in the active TDCS group had unusable data due to poor data quality.
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual/auditory frequency of interest.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=5 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Cross Modal Steady State Evoked Potential
Baseline
|
-0.129873057 decibels
Interval -0.351085988 to -0.039036888
|
-0.225582699 decibels
Interval -0.369160721 to -0.084290267
|
|
Cross Modal Steady State Evoked Potential
1 Month
|
-0.372064254 decibels
Interval -0.395091449 to -0.264603929
|
-0.370288832 decibels
Interval -0.480430263 to -0.146267599
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayMeasuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Resting State EEG
Baseline Delta/Theta Range (1-8hz)
|
-6.067479336 microvolts
Interval -8.358364857 to -5.444418054
|
-9.836502863 microvolts
Interval -10.87640284 to -6.060701682
|
|
Resting State EEG
Day 5 Delta/Theta Range (1-8hz)
|
-6.538377742 microvolts
Interval -8.949555683 to -5.160262915
|
-8.837371992 microvolts
Interval -11.64394669 to -7.549197399
|
|
Resting State EEG
Baseline Alpha (8-12hz)
|
-7.920960953 microvolts
Interval -10.83320875 to -7.295414497
|
-11.66579035 microvolts
Interval -13.69578824 to -7.820418988
|
|
Resting State EEG
Day 5 Alpha (8-12hz)
|
-7.433306198 microvolts
Interval -10.21438969 to -7.043908117
|
-10.07675116 microvolts
Interval -13.61574437 to -7.162213165
|
|
Resting State EEG
Baseline Beta (13-30hz)
|
-15.99107017 microvolts
Interval -16.44864468 to -15.41891723
|
-17.88706322 microvolts
Interval -18.60085714 to -16.64276514
|
|
Resting State EEG
Day 5 Beta (13-30hz)
|
-15.97882887 microvolts
Interval -16.30148928 to -15.67218914
|
-17.45169236 microvolts
Interval -17.80617123 to -15.82596502
|
|
Resting State EEG
Baseline Gamma (30-55hz)
|
-22.64365385 microvolts
Interval -23.36454231 to -21.38378251
|
-22.02556837 microvolts
Interval -24.09400191 to -20.51039388
|
|
Resting State EEG
Day 5 Gamma (30-55hz)
|
-23.79503055 microvolts
Interval -24.38033537 to -20.99613743
|
-22.638985 microvolts
Interval -23.25493645 to -21.12844812
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice' R package used for multiple imputation of 1 Month data
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Resting State EEG
Baseline Gamma (30-55hz)
|
-22.64365385 microvolts
Interval -23.36454231 to -21.38378251
|
-22.02556837 microvolts
Interval -24.09400191 to -20.51039388
|
|
Resting State EEG
1 Month Gamma (30-55hz)
|
-23.89591029 microvolts
Interval -24.94829518 to -22.12361733
|
-22.95515728 microvolts
Interval -24.30097235 to -22.21405322
|
|
Resting State EEG
Baseline Delta/Theta Range (1-8hz)
|
-6.067479336 microvolts
Interval -8.358364857 to -5.444418054
|
-9.836502863 microvolts
Interval -10.87640284 to -6.060701682
|
|
Resting State EEG
1 Month Delta/Theta Range (1-8hz)
|
-5.891239776 microvolts
Interval -7.30798828 to -4.582039071
|
-8.925939219 microvolts
Interval -10.09990467 to -7.862654867
|
|
Resting State EEG
Baseline Alpha (8-12hz)
|
-7.920960953 microvolts
Interval -10.83320875 to -7.295414497
|
-11.66579035 microvolts
Interval -13.69578824 to -7.820418988
|
|
Resting State EEG
1 Month Alpha (8-12hz)
|
-9.390036281 microvolts
Interval -10.94620211 to -8.24923518
|
-7.367402407 microvolts
Interval -9.002447243 to -7.084971382
|
|
Resting State EEG
Baseline Beta (12-30hz)
|
-15.99107017 microvolts
Interval -16.44864468 to -15.41891723
|
-17.88706322 microvolts
Interval -18.60085714 to -16.64276514
|
|
Resting State EEG
1 Month Beta (13-30hz)
|
-16.0281252 microvolts
Interval -17.60044849 to -15.79720705
|
-16.27626797 microvolts
Interval -18.23084259 to -15.95296812
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayMeasuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Biological Motion
Baseline
|
87.5 percentage correct
Interval 76.25 to 98.75
|
85 percentage correct
Interval 61.25 to 93.75
|
|
Biological Motion
Day 5
|
95 percentage correct
Interval 87.5 to 98.75
|
72.5 percentage correct
Interval 51.25 to 93.75
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice' R package used for multiple imputation of 1 Month data
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Biological Motion
Baseline
|
87.5 percentage correct
Interval 76.25 to 98.75
|
85 percentage correct
Interval 61.25 to 93.75
|
|
Biological Motion
1 Month
|
95 percentage correct
Interval 87.5 to 95.0
|
85 percentage correct
Interval 67.5 to 95.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayPopulation: Data was unable to be obtained for due to the a technique problem in code for the task that resulted in incorrectly quantifying outcomes.
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: Data was unable to be obtained for due to the a technique problem in code for the task that resulted in incorrectly quantifying outcomes.
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to day 5Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Global Assessment of Function (GAF)
Baseline
|
60.5 score on a scale
Interval 53.25 to 64.0
|
57.5 score on a scale
Interval 43.75 to 60.0
|
|
Global Assessment of Function (GAF)
Day 5
|
60.5 score on a scale
Interval 52.5 to 67.75
|
53 score on a scale
Interval 42.75 to 58.75
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice' R package used for multiple imputation on 1 Month data
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Global Assessment of Function (GAF)
Baseline
|
60.5 score on a scale
Interval 53.25 to 64.0
|
57.5 score on a scale
Interval 43.75 to 60.0
|
|
Global Assessment of Function (GAF)
1 Month
|
61.5 score on a scale
Interval 56.25 to 68.25
|
54 score on a scale
Interval 51.5 to 59.5
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayMeasuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline
|
7 score on a scale
Interval 3.5 to 16.5
|
7.5 score on a scale
Interval 4.75 to 10.25
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Day 5
|
6 score on a scale
Interval 2.5 to 18.5
|
13.5 score on a scale
Interval 5.5 to 20.0
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice' R package used for multiple imputation on 1 Month data
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline
|
7 score on a scale
Interval 3.5 to 16.5
|
7.5 score on a scale
Interval 4.75 to 10.25
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
1 Month
|
5.5 score on a scale
Interval 4.25 to 19.5
|
13 score on a scale
Interval 10.5 to 15.5
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayMeasuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
Baseline
|
2.25 score on a scale
Interval 0.625 to 14.0
|
7 score on a scale
Interval 3.625 to 11.875
|
|
Young Mania Rating Scale (YMRS)
Day 5
|
1.25 score on a scale
Interval 0.125 to 11.375
|
14 score on a scale
Interval 6.375 to 14.875
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice" R package used for multiple imputation on 1 Month data
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
Baseline
|
2.25 score on a scale
Interval 0.625 to 14.0
|
7 score on a scale
Interval 3.625 to 11.875
|
|
Young Mania Rating Scale (YMRS)
1 Month
|
2 score on a scale
Interval 1.25 to 10.25
|
8.75 score on a scale
Interval 5.25 to 14.875
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayPopulation: BACS total score reported. Summed from all subcategories of cognition (memory, working memory, processing speed, executive function and verbal fluency scores). Scores transformed into Z scores based off standardized transformations provided by the test makers. 0 represents the population mean for healthy controls. Standard deviations above the mean represent better cognitive ability.
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Brief Assessment of Cognition (BACS)
Baseline
|
0.58 z score on test
Interval -0.7075 to 1.005
|
-0.8 z score on test
Interval -1.5325 to -0.4275
|
|
Brief Assessment of Cognition (BACS)
Day 5
|
-0.15 z score on test
Interval -1.355 to 0.5375
|
-1.065 z score on test
Interval -1.7775 to -0.5475
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice" R package used for multiple imputation on 1 Month data; BACS total score reported. BACS total score reported. Summed from all subcategories of cognition (memory, working memory, processing speed, executive function and verbal fluency scores). Scores transformed into Z scores based off standardized transformations provided by the test makers. 0 represents the population mean for healthy controls. Standard deviations above the mean represent better cognitive ability.
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Brief Assessment of Cognition (BACS)
Baseline
|
0.58 z score on test
Interval -0.7075 to 1.005
|
-0.8 z score on test
Interval -1.5325 to -0.4275
|
|
Brief Assessment of Cognition (BACS)
1 Month
|
-0.07 z score on test
Interval -0.5775 to 0.7525
|
-1.425 z score on test
Interval -1.825 to -0.8225
|
SECONDARY outcome
Timeframe: Change from baseline to 5 dayPopulation: Total score assesses psychological distress through 90 items reported. Total score reported, range 0 to 360.
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms. Total score range 0 to 360
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Symptom Checklist-90
Baseline
|
56.5 score on a scale
Interval 21.75 to 119.75
|
81.5 score on a scale
Interval 56.5 to 95.25
|
|
Symptom Checklist-90
Day 5
|
33 score on a scale
Interval 9.25 to 56.0
|
84.5 score on a scale
Interval 69.25 to 95.25
|
SECONDARY outcome
Timeframe: Change from baseline to month follow-upPopulation: 'Mice' R package used for multiple imputation on missing data. Total score assesses psychological distress through 90 items reported. Total score reported, range 0 to 360.
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms.Total score range 0 to 360.
Outcome measures
| Measure |
Active Stimulation With TDCS
n=6 Participants
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 Participants
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Symptom Checklist-90
Baseline
|
56.5 score on a scale
Interval 21.75 to 119.75
|
81.5 score on a scale
Interval 56.5 to 95.25
|
|
Symptom Checklist-90
1 Month
|
42 score on a scale
Interval 16.5 to 102.0
|
95.5 score on a scale
Interval 79.5 to 124.25
|
Adverse Events
Active Stimulation With TDCS
SHAM Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Stimulation With TDCS
n=6 participants at risk
tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
SHAM Stimulation
n=6 participants at risk
Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Up to 1 month period after study participation
|
16.7%
1/6 • Number of events 1 • Up to 1 month period after study participation
|
|
Nervous system disorders
Lightheadness
|
0.00%
0/6 • Up to 1 month period after study participation
|
16.7%
1/6 • Number of events 1 • Up to 1 month period after study participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place