Trial Outcomes & Findings for Feasibility Electrical Stimulation Study for Visual Hallucinations (NCT NCT04870710)
NCT ID: NCT04870710
Last Updated: 2025-06-12
Results Overview
Measuring the average evoked response potential amplitude change for P100 at Baseline, 5 day and 1 month visits. ssVEP was utilized to measure changes in electrical biomarkers of the early visual response. Stimuli consisted of 50 trials of a black and white square oscillating at 18.75 Hz in the subject's central, bilateral, left, or right visual field for 2000 ms (200 total trials pseudorandomly interleaved) with inter-trial intervals of 2.5 seconds.
COMPLETED
NA
6 participants
Measured at day 5 compared to day 0
2025-06-12
Participant Flow
Recruitment efforts ended prior to the end of the trial (Jan 2, 2022) resulting with 6 individuals who met criteria for schizophrenia, schizoaffective or bipolar disorder entering the study. Recruitment efforts were done through utilizing past research repositories and individuals were contacted through email or phone. Interested individuals were then phone screened for additional study criteria including safety to receive transcranial electrical stimulation (tES) and current symptoms.
Participants were first consented and met with a trained medical professor review any medical changes or relevant changes to diagnosis to ensure safe measures for tES treatment. Individuals who were recruited were then requested to completed a clinical assignment as well as baseline measurements for EEG and behavioral tasks before receiving any tES treatment.
Participant milestones
| Measure |
Transcranial Electrical Stimulation (tES)
Two, twenty minute sessions of cathodal cathodal transcranial direct current stimulation (tDCS) to the bilateral extrastriate visual cortex for 5 days (10 total sessions). After which individuals entered the transcranial alternating current stimulation (tACS) arm of the study which followed the same treatment parameters as the tDCS arm.
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
Transcranial Direct Current Stimulation (tDCS) Baseline Assessment
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6
|
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Overall Study
Transcranial Direct Current Stimulation (tDCS) Five Day Follow-up Assessment
|
6
|
|
Overall Study
Transcranial Direct Current Stimulation (tDCS) 1 Month Follow-up Assessment
|
5
|
|
Overall Study
Transcranial Alternating Current Stimulation (tACS) Baseline Assessment
|
4
|
|
Overall Study
Transcranial Alternating Current Stimulation (tACS) 5 Day Follow up Assessment
|
4
|
|
Overall Study
Transcranial Alternating Current Stimulation (tACS) 1 Month Follow up Assessment
|
3
|
|
Overall Study
COMPLETED
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3
|
|
Overall Study
NOT COMPLETED
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3
|
Reasons for withdrawal
| Measure |
Transcranial Electrical Stimulation (tES)
Two, twenty minute sessions of cathodal cathodal transcranial direct current stimulation (tDCS) to the bilateral extrastriate visual cortex for 5 days (10 total sessions). After which individuals entered the transcranial alternating current stimulation (tACS) arm of the study which followed the same treatment parameters as the tDCS arm.
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
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|---|---|
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Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Feasibility Electrical Stimulation Study for Visual Hallucinations
Baseline characteristics by cohort
| Measure |
Transcranial Electrical Stimualtion
n=6 Participants
After participants performed a clinical assignment, EEG and behavioral tasks they were entered into the treatment phase of the study. Individuals first received two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions). After which, and additional clinical assignment, EEG and behavioral task battery were performed on day 5. Participants were then asked to come back in a month for an additional follow up visit that consisted of a clinical assignment, EEG and behavioral task battery. Participants were then scheduled to entered the 2hz tACS condition after they completed a minimum 2 week washout period. individuals were allocated to receive two, twenty minute sessions of 2hz tACS to the bilateral extrastriate visual cortex for 5 days (10 total sessions). At day 5, another clinical assignment, EEG and behavioral task battery was preformed. Participants were then asked to come back after 1month to receive an additional follow up visit.
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|---|---|
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Age, Continuous
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29.67 years
STANDARD_DEVIATION 2.58 • n=5 Participants
|
|
Sex/Gender, Customized
Male
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2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Measured at day 5 compared to day 0Measuring the average evoked response potential amplitude change for P100 at Baseline, 5 day and 1 month visits. ssVEP was utilized to measure changes in electrical biomarkers of the early visual response. Stimuli consisted of 50 trials of a black and white square oscillating at 18.75 Hz in the subject's central, bilateral, left, or right visual field for 2000 ms (200 total trials pseudorandomly interleaved) with inter-trial intervals of 2.5 seconds.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
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|---|---|---|
|
Steady State Visual Evoked Potential (ssVEP)
Baseline
|
1.725 microvolts
Interval 0.91 to 3.035
|
1.160 microvolts
Interval 0.48 to 2.933
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|
Steady State Visual Evoked Potential (ssVEP)
Day 5
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1.180 microvolts
Interval 0.503 to 2.053
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1.005 microvolts
Interval 0.483 to 3.238
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PRIMARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Measuring the average evoked response potential amplitude change for P100 at Baseline, 5 day and 1 month visits. ssVEP was utilized to measure changes in electrical biomarkers of the early visual response. Stimuli consisted of 50 trials of a black and white square oscillating at 18.75 Hz in the subject's central, bilateral, left, or right visual field for 2000 ms (200 total trials pseudorandomly interleaved) with inter-trial intervals of 2.5 seconds.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Steady State Visual Evoked Potential (ssVEP)
Baseline
|
1.725 microvolts
Interval 0.91 to 3.035
|
1.160 microvolts
Interval 0.48 to 2.933
|
|
Steady State Visual Evoked Potential (ssVEP)
5 day
|
1.180 microvolts
Interval 0.503 to 2.053
|
1.005 microvolts
Interval 0.483 to 3.238
|
|
Steady State Visual Evoked Potential (ssVEP)
1 Month
|
1.160 microvolts
Interval 0.218 to 2.86
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2.560 microvolts
Interval 1.035 to 4.412
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PRIMARY outcome
Timeframe: Measured at day 5 compared to day 0Measuring total psychosis symptoms score. PANSS is a clinician administered instrument which has 30 items measuring a range of symptoms which are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme). A total score ranges from 30-210 with higher scores indicate worsen symptoms. Subscales include, general, negative and positive symptom categories with higher scores indicate worsen symptoms. The range for the positive and negative Scales is 7-49, and the range for the general Psychopathology Scale is 16-112.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
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|---|---|---|
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Positive and Negative Syndrome Scale (PANSS)
Baseline
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49.50 score on a scale
Interval 43.5 to 59.25
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59.50 score on a scale
Interval 54.5 to 67.5
|
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Positive and Negative Syndrome Scale (PANSS)
5 Day
|
44.00 score on a scale
Interval 40.5 to 49.75
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56.50 score on a scale
Interval 50.5 to 64.75
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PRIMARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Measuring total psychosis symptoms score. PANSS is a clinician administered instrument which has 30 items measuring a range of symptoms which are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme). A total score ranges from 30-210 with higher scores indicate worsen symptoms. Subscales include, general, negative and positive symptom categories with higher scores indicate worsen symptoms. The range for the positive and negative Scales is 7-49, and the range for the general Psychopathology Scale is 16-112.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
49.50 units on a scale
Interval 43.5 to 59.25
|
59.50 units on a scale
Interval 54.5 to 67.5
|
|
Positive and Negative Syndrome Scale (PANSS)
Day 5
|
44.00 units on a scale
Interval 40.5 to 49.75
|
56.50 units on a scale
Interval 50.5 to 64.75
|
|
Positive and Negative Syndrome Scale (PANSS)
1 Month
|
50.00 units on a scale
Interval 48.25 to 54.75
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47.50 units on a scale
Interval 43.75 to 52.0
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PRIMARY outcome
Timeframe: Measured at day 5 compared to day 0Measuring the percent correct of detected motion. Biological motion perception was assessed using point-light animations (12 dots on the head and major joints of the body) walking either rightward or leftward. The target animation was embedded in a number of random-moving noise dots (24, 48, or 72) to manipulate the difficulty level of the task. Participants were asked to indicate the direction that the animation was walking towards. The task lasted for about 4 minutes.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
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Biological Motion
Baseline
|
63.33 percentage of correct responses
Interval 57.08 to 70.83
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60.00 percentage of correct responses
Interval 52.5 to 69.17
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Biological Motion
5 Day
|
68.33 percentage of correct responses
Interval 58.33 to 77.08
|
71.67 percentage of correct responses
Interval 63.33 to 79.17
|
PRIMARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Measuring the percent correct of detected motion. Biological motion perception was assessed using point-light animations (12 dots on the head and major joints of the body) walking either rightward or leftward. The target animation was embedded in a number of random-moving noise dots (24, 48, or 72) to manipulate the difficulty level of the task. Participants were asked to indicate the direction that the animation was walking towards. The task lasted for about 4 minutes.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Biological Motion
Baseline
|
63.33 percentage of correct responses
Interval 57.08 to 70.83
|
60.00 percentage of correct responses
Interval 52.5 to 69.17
|
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Biological Motion
5 Day
|
68.33 percentage of correct responses
Interval 58.33 to 77.08
|
71.67 percentage of correct responses
Interval 63.33 to 79.17
|
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Biological Motion
1 Month
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69.17 percentage of correct responses
Interval 62.5 to 78.33
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60.00 percentage of correct responses
Interval 59.17 to 74.17
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SECONDARY outcome
Timeframe: Measured at day 5 compared to day 0Population: 1 individual in our sample pool did not feel comfortable completing the task, leaving us with 5 individuals in the tDCS condition for analysis. Too few individuals in the tACS completed the task for effective analysis and data was deemed poor quality or insufficient to process.
Emotional evoked related potential (ERP) measures were obtained using the IAPS, which consists of unpleasant, pleasant, and neutral scene stimuli. Scenes consisted of human threat, animal threat, erotica, romantic couples, people, families, and landscapes. During each experimental session, participants viewed each scene three times. Images were presented for 1000 ms and then followed by 3.5 s of a black screen with a small red dot as a fixation point.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=5 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
International Affective Picture System (IAPS) Task
Baseline
|
6.525 microvolts
Interval 6.348 to 6.787
|
—
|
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International Affective Picture System (IAPS) Task
5 Day
|
5.751 microvolts
Interval 5.139 to 5.856
|
—
|
SECONDARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Population: 1 individual in our sample pool did not feel comfortable completing the task, leaving us with 5 individuals in the tDCS condition for analysis. Too few individuals in the tACS completed the task for effective analysis and data that was collected was insufficient quality to process through software.
Emotional evoked related potential (ERP) measures were obtained using the IAPS, which consists of unpleasant, pleasant, and neutral scene stimuli. Scenes consisted of human threat, animal threat, erotica, romantic couples, people, families, and landscapes. During each experimental session, participants viewed each scene three times. Images were presented for 1000 ms and then followed by 3.5 s of a black screen with a small red dot as a fixation point.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=5 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
International Affective Picture System (IAPS) Task
5 Day
|
5.751 microvolts
Interval 5.139 to 5.856
|
—
|
|
International Affective Picture System (IAPS) Task
1 Month
|
3.25 microvolts
Interval 3.247 to 4.348
|
—
|
|
International Affective Picture System (IAPS) Task
Baseline
|
6.525 microvolts
Interval 6.348 to 6.787
|
—
|
SECONDARY outcome
Timeframe: Measured at day 5 compared to day 0Population: Too few individuals met threshold requirements related to task to perform analysis for Velocity Discrimination due to insufficient data/poor quality or participant drop out.
Velocity discrimination performance was determined using constant stimuli method. Participants asked to indicate the faster of the two gradients (drifting Gabor patches) presented sequentially for 300 ms with an inter-stimulus interval of 500ms 51.There were 9 velocity difference levels to modulate the difficulty of the task. 15 trials were presented at each difficulty level. Velocity discrimination thresholds, which corresponds to an accuracy level equivalent to 75% correct for each subject, calculated as an indicator of performance. This task session lasted for about 5 minutes.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=5 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=3 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Velocity Discrimination
Baseline
|
0.181 percentage of total correct
Interval 0.123 to 0.205
|
0.2020 percentage of total correct
Interval 0.151 to 0.216
|
|
Velocity Discrimination
5 Day Follow up
|
0.188 percentage of total correct
Interval 0.168 to 0.218
|
0.1600 percentage of total correct
Interval 0.0875 to 0.17
|
SECONDARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Population: Too few individuals met threshold requirements related to task to perform analysis for Velocity Discrimination. This was due to insufficient data/poor quality or participant drop out.
Velocity discrimination performance was determined using constant stimuli method. Participants asked to indicate the faster of the two gradients (drifting Gabor patches) presented sequentially for 300 ms with an inter-stimulus interval of 500ms 51.There were 9 velocity difference levels to modulate the difficulty of the task. 15 trials were presented at each difficulty level. Velocity discrimination thresholds, which corresponds to an accuracy level equivalent to 75% correct for each subject, calculated as an indicator of performance. This task session lasted for about 5 minutes.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=5 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=3 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Velocity Discrimination
Baseline
|
0.181 percentage of total correct
Interval 0.123 to 0.205
|
0.2020 percentage of total correct
Interval 0.151 to 0.216
|
|
Velocity Discrimination
5 Day
|
0.188 percentage of total correct
Interval 0.168 to 0.218
|
0.1600 percentage of total correct
Interval 0.0875 to 0.17
|
|
Velocity Discrimination
1 Month
|
0.188 percentage of total correct
Interval 0.167 to 0.202
|
0.17 percentage of total correct
Interval 0.17 to 0.17
|
SECONDARY outcome
Timeframe: Measured at day 5 compared to day 0To assess visuospatial working memory participants were asked to identify and remember the location of the odd shape out of three shapes. The procedure was repeated with three new shapes following an interval. Participants were asked to respond by indicating where the odd shapes appeared, in the correct order of appearance. Two correct trials on each level led to progression to the next level where the item load was increased by one. The session was terminated when two trials on the same level were incorrect. The final score was calculated based on the performance on the highest level achieved (10 max) where at least one trial was passed. A higher score means better visual spatial memory capability (0-10) and the highest difficulty level achieved. This task lasted for 3-5 minutes.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Visual Spatial Working Memory
Baseline
|
5.925 score on a scale
Interval 4.763 to 6.3
|
5.000 score on a scale
Interval 4.775 to 5.125
|
|
Visual Spatial Working Memory
5 Day
|
5.250 score on a scale
Interval 4.612 to 5.7
|
4.700 score on a scale
Interval 4.275 to 5.05
|
SECONDARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5To assess visuospatial working memory participants were asked to identify and remember the location of the odd shape out of three shapes. The procedure was repeated with three new shapes following an interval. Participants were asked to respond by indicating where the odd shapes appeared, in the correct order of appearance. Two correct trials on each level led to progression to the next level where the item load was increased by one. The session was terminated when two trials on the same level were incorrect. The final score was calculated based on the performance on the highest level achieved (10 max) where at least one trial was passed. A higher score means better visual spatial memory capability (0-10) and the highest difficulty level achieved. This task lasted for 3-5 minutes.
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Visual Spatial Working Memory
Baseline
|
5.925 score on a scale
Interval 4.763 to 6.3
|
5.000 score on a scale
Interval 4.775 to 5.125
|
|
Visual Spatial Working Memory
Day 5
|
5.250 score on a scale
Interval 4.612 to 5.7
|
4.700 score on a scale
Interval 4.275 to 5.05
|
|
Visual Spatial Working Memory
1 Month
|
6.475 score on a scale
Interval 5.612 to 7.3
|
5.250 score on a scale
Interval 4.9 to 5.325
|
SECONDARY outcome
Timeframe: Measured at day 5 compared to day 0Measuring global functioning derived from patients symptoms, relationships and functioning in life. The higher the score, the better individual handles daily activities and lower symptoms experienced. 91-100 No symptoms. Superior functioning in a wide range of activities. 81-90 Absent or minimal symptoms, good functioning in all areas. 71-80 Symptoms are transient and expectable reactions to psychosocial stressors. 61-70 Some mild symptoms or some difficulty in functioning. 51-60 Moderate symptoms or moderate difficulty in functioning. 41-50 Serious symptoms or any serious impairment in functioning 31-40 Some impairment or major impairment in several areas, such as work or school, family relations, judgment, thinking, or mood. 21-30 Behavior is considerably influenced by delusions or hallucinations or serious impairment 11-20 Some danger of hurting self or others. 1-10 Persistent danger of severely hurting self or others. 0 Inadequate information
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Global Assessment of Function (GAF)
Baseline
|
70.00 score on a scale
Interval 62.0 to 78.75
|
65.00 score on a scale
Interval 60.0 to 66.25
|
|
Global Assessment of Function (GAF)
5 Day
|
68.50 score on a scale
Interval 61.25 to 78.75
|
65.00 score on a scale
Interval 61.75 to 66.25
|
SECONDARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Measuring global functioning derived from patients symptoms, relationships and functioning in life. The higher the score, the better individual handles daily activities and lower symptoms experienced. 91-100 No symptoms. Superior functioning in a wide range of activities. 81-90 Absent or minimal symptoms, good functioning in all areas. 71-80 Symptoms are transient and expectable reactions to psychosocial stressors. 61-70 Some mild symptoms or some difficulty in functioning. 51-60 Moderate symptoms or moderate difficulty in functioning. 41-50 Serious symptoms or any serious impairment in functioning 31-40 Some impairment or major impairment in several areas, such as work or school, family relations, judgment, thinking, or mood. 21-30 Behavior is considerably influenced by delusions or hallucinations or serious impairment 11-20 Some danger of hurting self or others. 1-10 Persistent danger of severely hurting self or others. 0 Inadequate information
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Global Assessment of Function (GAF)
Baseline
|
70.00 score on a scale
Interval 62.0 to 78.75
|
65.00 score on a scale
Interval 60.0 to 66.25
|
|
Global Assessment of Function (GAF)
5 Day
|
68.50 score on a scale
Interval 61.25 to 78.75
|
65.00 score on a scale
Interval 61.75 to 66.25
|
|
Global Assessment of Function (GAF)
1 Month
|
63.00 score on a scale
Interval 53.5 to 65.0
|
68.00 score on a scale
Interval 65.75 to 72.5
|
SECONDARY outcome
Timeframe: Measured at day 5 compared to day 0Measuring total depression scores, The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists or trained mental health providers use to measure the severity of depressive episodes and or symptoms in patients with mood disorders. A higher score indicates worsen depression. The questionnaire includes questions on ten symptoms:Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, Suicidal thoughts. Total used from scale indicates: 0 to 6: normal/symptom absent 7 to 19: mild depression 20 to 34: moderate depression 35 to 60: severe depression
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline
|
6.00 score on a scale
Interval 4.25 to 15.25
|
5.50 score on a scale
Interval 3.75 to 10.0
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
5 Day
|
3.50 score on a scale
Interval 3.0 to 5.5
|
4.00 score on a scale
Interval 2.25 to 8.0
|
SECONDARY outcome
Timeframe: Measured at day 30 compared to day 0 and day 5Measuring total depression scores, The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists or trained mental health providers use to measure the severity of depressive episodes and or symptoms in patients with mood disorders. A higher score indicates worsen depression. The questionnaire includes questions on ten symptoms:Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, Suicidal thoughts. Total used from scale indicates: 0 to 6: normal/symptom absent 7 to 19: mild depression 20 to 34: moderate depression 35 to 60: severe depression
Outcome measures
| Measure |
Cathodal Transcranial Direct Current Stimulation (tDCS)
n=6 Participants
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
Anodal Transcranial Alternating Current Stimulation (tACS)
n=4 Participants
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
transcranial electrical stimulation: Electrical stimulation to the extrastriate visual cortex.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline
|
6.00 units on a scale
Interval 4.25 to 15.25
|
5.50 units on a scale
Interval 3.75 to 10.0
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Day 5
|
3.50 units on a scale
Interval 3.0 to 5.5
|
4.00 units on a scale
Interval 2.25 to 8.0
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
1 Month
|
6.00 units on a scale
Interval 2.0 to 7.75
|
2.50 units on a scale
Interval 0.0 to 5.5
|
Adverse Events
Cathodal Transcranial Direct Current Stimulation (tDCS)
2hz Transcranial Alternating Current Stimulation (tACS)
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