An interventional study of transcranial electrical stimulation in Schizophrenia, Schizoaffective Disorder and Bipolar Disorder, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
The visual system has increasingly been recognized as an important site of injury in patients with schizophrenia and other psychoses. Visual system alterations manifest as visual perceptual aberrations, deficits in visual processing, and visual hallucinations. These visual symptoms are associated with worse symptoms, poorer outcome and resistance to treatment. A recent study using brain lesion mapping of visual hallucinations and identified a causal location in the part of the brain that processes visual information (visual cortex). The association between visual cortex activation and visual hallucinations suggests that this region could be targeted using noninvasive brain stimulation. Two case studies have found that brain stimulation to the visual cortex improved visual hallucinations in treatment resistant patients with psychosis. While promising it is unclear whether these symptom reductions resulted from activity changes in the visual cortex or not. Here we aim to answer the question whether noninvasive brain stimulation when optimally targeted to the visual cortex can improve brain activity, visual processing and visual hallucinations. The knowledge gained from this study will contribute to the field of vision by providing a marker for clinical response and by personalizing treatment for patients with psychosis suffering from visual symptoms. This grant will allow us to set the foundation for a larger more targeted study utilizing noninvasive brain stimulation to improve visual symptoms in patients with psychosis.
The visual system has increasingly been recognized as an important site of pathology in patients with schizophrenia and other psychoses. Visual system impairments manifest as visual perceptual aberrations, deficits in visual processing tasks, and visual hallucinations (VH). In psychosis spectrum disorders, increased visual aberrations are strongly correlated with worse hallucinations and delusions. It is also recognized that poorer performance on visual spatial working memory, visual integration, and velocity discrimination tasks are associated with greater negative symptoms (a major contributor to disability). VH are common in psychotic disorders (30-70% prevalence) and can be refractory to existing treatments. VH have been understudied in psychosis with much of the literature focusing on auditory hallucinations. Despite the neuroscientific and clinical significance of VH, the brain regions responsible are less clear.
Functional neuroimaging studies have identified neural correlates of VH across multiple brain regions (lingual, fusiform, cuneus, lateral geniculate nucleus, and occipital cortex) and support hypotheses that increased visual cortex activity and sensory cortex over-stimulation generate VH. However, whether these neuroimaging findings represented a cause, consequence or incidental correlate of VH was unclear until recently. Using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of VH can occur in different brain locations, both inside and outside sensory pathways, and that these lesions are functionally connected to the lateral geniculate nucleus, a major relay center for the visual pathway. They also found that 98% of the subcortical and cortical lesions were connected to the exact same location in the extrastriate visual cortex. Therefore, the association between extrastriate visual cortex activation and VH would suggest this region may be optimal for modulation via brain stimulation.
One method by which cortical excitability can be altered is through the use of transcranial electrical stimulation (tES), a non-invasive brain stimulation technique. High definition tES (HD-tES) is a refined version of tES with improved spatial precision of cortical stimulation. This involves the application of a weak electrical current (1-2 mA) delivered to the brain via scalp electrodes. The effects of tES modulate cortical excitability where anodal stimulation tends to increase (i.e. the resting potential becomes less negative) and cathodal stimulation tends to decrease the underlying membrane potential (i.e. the resting potential becomes more negative) (14,15). Studies have shown that tES can modulate visual cortical function in a polarity-dependent manner, where anodal stimulation can increase and cathodal stimulation can decrease the amplitude of the N70 component from the visual-evoked potential. While tES is a promising adjunctive treatment of auditory hallucinations and negative symptoms in schizophrenia, less is known about its role in treating VH. To date, two cases have been described where cathodal tES (i.e., outward current flow) over the occipital area was applied to patients experiencing treatment refractory VH, and this resulted in symptomatic improvement. Taken together, the recent lesion network mapping identifying the extrastriate visual cortex as a major source of VH in schizophrenia combined with these two single-patient case studies suggest that it may be possible to alleviate VH by designing a tES protocol that targets the extrastriate visual cortex bilaterally. Technological advances in noninvasive neuromodulation and electrical field modeling further allow us to create a tES protocol specifically guided by the results of lesion network mapping studies (i.e., using the exact Montreal Neurological Institute coordinates) with high spatial resolution (i.e., using HD-tES).
Exclusion Criteria:
Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).
Device: transcranial electrical stimulation
Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).
Device: transcranial electrical stimulation
Electrical stimulation to the extrastriate visual cortex.
Steady State Visual Evoked Potential (ssVEP)
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.
Time frame: Measured at day 5 compared to day 0
Steady State Visual Evoked Potential (ssVEP)
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.
Time frame: Measured at day 30 compared to day 0 and day 5
Positive and Negative Syndrome Scale (PANSS)
Measuring 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.
Time frame: Measured at day 5 compared to day 0
Positive and Negative Syndrome Scale (PANSS)
Measuring 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.
Time frame: Measured at day 30 compared to day 0 and day 5
Biological Motion
Measuring 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.
Time frame: Measured at day 5 compared to day 0
Biological Motion
Measuring 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.
Time frame: Measured at day 30 compared to day 0 and day 5
International Affective Picture System (IAPS) Task
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.
Time frame: Measured at day 5 compared to day 0
International Affective Picture System (IAPS) Task
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.
Time frame: Measured at day 30 compared to day 0 and day 5
Velocity Discrimination
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.
Time frame: Measured at day 5 compared to day 0
Velocity Discrimination
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.
Time frame: Measured at day 30 compared to day 0 and day 5
Visual Spatial Working Memory
To 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.
Time frame: Measured at day 5 compared to day 0
Visual Spatial Working Memory
To 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.
Time frame: Measured at day 30 compared to day 0 and day 5
Global Assessment of Function (GAF)
Measuring 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
Time frame: Measured at day 5 compared to day 0
Global Assessment of Function (GAF)
Measuring 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
Time frame: Measured at day 30 compared to day 0 and day 5
Montgomery-Asberg Depression Rating Scale (MADRS)
Measuring 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
Time frame: Measured at day 5 compared to day 0
Montgomery-Asberg Depression Rating Scale (MADRS)
Measuring 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
Time frame: Measured at day 30 compared to day 0 and day 5
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.
| Milestone | Transcranial Electrical Stimulation (tES) |
|---|---|
| Started | 6 |
| Transcranial direct current stimulation (tdcs) baseline assessment | 6 |
| Transcranial direct current stimulation (tdcs) five day follow-up assessment | 6 |
| Transcranial direct current stimulation (tdcs) 1 month follow-up assessment | 5 |
| Transcranial alternating current stimulation (tacs) baseline assessment | 4 |
| Transcranial alternating current stimulation (tacs) 5 day follow up assessment | 4 |
| Transcranial alternating current stimulation (tacs) 1 month follow up assessment | 3 |
| Completed | 3 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
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.
| microvolts | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 1.725 (0.910 to 3.035) | 1.160 (0.480 to 2.933) |
| Day 5 | 1.180 (0.503 to 2.053) | 1.005 (0.483 to 3.238) |
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.
| microvolts | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 1.725 (0.910 to 3.035) | 1.160 (0.480 to 2.933) |
| 5 day | 1.180 (0.503 to 2.053) | 1.005 (0.483 to 3.238) |
| 1 Month | 1.160 (0.218 to 2.860) | 2.560 (1.035 to 4.412) |
Measuring 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.
| score on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 49.50 (43.50 to 59.25) | 59.50 (54.50 to 67.50) |
| 5 Day | 44.00 (40.50 to 49.75) | 56.50 (50.50 to 64.75) |
Measuring 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.
| units on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 49.50 (43.50 to 59.25) | 59.50 (54.50 to 67.50) |
| Day 5 | 44.00 (40.50 to 49.75) | 56.50 (50.50 to 64.75) |
| 1 Month | 50.00 (48.25 to 54.75) | 47.50 (43.75 to 52.00) |
Measuring 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.
| percentage of correct responses | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 63.33 (57.08 to 70.83) | 60.00 (52.50 to 69.17) |
| 5 Day | 68.33 (58.33 to 77.08) | 71.67 (63.33 to 79.17) |
Measuring 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.
| percentage of correct responses | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 63.33 (57.08 to 70.83) | 60.00 (52.50 to 69.17) |
| 5 Day | 68.33 (58.33 to 77.08) | 71.67 (63.33 to 79.17) |
| 1 Month | 69.17 (62.50 to 78.33) | 60.00 (59.17 to 74.17) |
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.
| microvolts | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 6.525 (6.348 to 6.787) | — |
| 5 Day | 5.751 (5.139 to 5.856) | — |
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.
| microvolts | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 6.525 (6.348 to 6.787) | — |
| 5 Day | 5.751 (5.139 to 5.856) | — |
| 1 Month | 3.25 (3.247 to 4.348) | — |
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.
| percentage of total correct | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 0.181 (0.123 to 0.205) | 0.2020 (0.1510 to 0.2160) |
| 5 Day Follow up | 0.188 (0.168 to 0.218) | 0.1600 (0.0875 to 0.1700) |
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.
| percentage of total correct | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 0.181 (0.123 to 0.205) | 0.2020 (0.1510 to 0.2160) |
| 5 Day | 0.188 (0.168 to 0.218) | 0.1600 (0.0875 to 0.1700) |
| 1 Month | 0.188 (0.167 to 0.202) | 0.17 (0.17 to 0.17) |
To 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.
| score on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 5.925 (4.763 to 6.300) | 5.000 (4.775 to 5.125) |
| 5 Day | 5.250 (4.612 to 5.700) | 4.700 (4.275 to 5.050) |
To 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.
| score on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 5.925 (4.763 to 6.300) | 5.000 (4.775 to 5.125) |
| Day 5 | 5.250 (4.612 to 5.700) | 4.700 (4.275 to 5.050) |
| 1 Month | 6.475 (5.612 to 7.300) | 5.250 (4.900 to 5.325) |
Measuring 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
| score on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 70.00 (62.00 to 78.75) | 65.00 (60.00 to 66.25) |
| 5 Day | 68.50 (61.25 to 78.75) | 65.00 (61.75 to 66.25) |
Measuring 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
| score on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 70.00 (62.00 to 78.75) | 65.00 (60.00 to 66.25) |
| 5 Day | 68.50 (61.25 to 78.75) | 65.00 (61.75 to 66.25) |
| 1 Month | 63.00 (53.50 to 65.00) | 68.00 (65.75 to 72.50) |
Measuring 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
| score on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 6.00 (4.25 to 15.25) | 5.50 (3.75 to 10.00) |
| 5 Day | 3.50 (3.00 to 5.50) | 4.00 (2.25 to 8.00) |
Measuring 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
| units on a scale | Cathodal Transcranial Direct Current Stimulation (tDCS) | Anodal Transcranial Alternating Current Stimulation (tACS) |
|---|---|---|
| Baseline | 6.00 (4.25 to 15.25) | 5.50 (3.75 to 10.00) |
| Day 5 | 3.50 (3.00 to 5.50) | 4.00 (2.25 to 8.00) |
| 1 Month | 6.00 (2.00 to 7.75) | 2.50 (0.00 to 5.50) |
Collected over Data related to adverse events were collected up to study completion or at each assessment time point (baseline, day 5 and 1month). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cathodal Transcranial Direct Current Stimulation (tDCS) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| 2hz Transcranial Alternating Current Stimulation (tACS) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
The total number of participates recruited was 6 individuals. However, we utilized a cross-over design with 6 individuals completing the cathodal tDCS condition (baseline and day 5) and 4 individuals completing the tACS condition (baseline and day 5) .
| Age, Continuous(years) | Transcranial Electrical Stimualtion |
|---|---|
| Mean | 29.67 ± 2.58 |
| Sex/Gender, Customized(Participants) | Transcranial Electrical Stimualtion |
|---|---|
| Male | 2 |
| Female | 3 |
| Transgender | 1 |
| Race (NIH/OMB)(Participants) | Transcranial Electrical Stimualtion |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 3 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center