Adults 18 to 65, any sex, with Bipolar Disorder or Schizo Affective Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Young Mania Rating Scale (YMRS)Primary· Change from baseline to 5 Day follow-up
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Baseline
Group
Value
95% CI
HD-tDCS
5.5
0.5 – 6
HD-tACS (Alpha, 10 Hz)
11.8
9.575 – 13.25
Personalized Beta-Gamma tACS
7.5
5.5 – 8
Day 5
Group
Value
95% CI
HD-tDCS
3
2 – 3.5
HD-tACS (Alpha, 10 Hz)
8
4.75 – 11.125
Personalized Beta-Gamma tACS
3
1.5 – 13
Young Mania Rating Scale (YMRS)Primary· Change from baseline to 1-month follow-up
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Baseline
Group
Value
95% CI
HD-tDCS
5.5
0.5 – 6
HD-tACS (Alpha, 10 Hz)
11.8
9.575 – 13.25
Personalized Beta-Gamma tACS
7.5
5.5 – 8
1 Month
Group
Value
95% CI
HD-tDCS
1.5
1.5 – 4
HD-tACS (Alpha, 10 Hz)
11
8 – 14.25
Personalized Beta-Gamma tACS
4
1.5 – 5.5
Young Mania Rating Scale (YMRS)Primary· Change from baseline to 3-month follow-up
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Baseline
Group
Value
95% CI
HD-tDCS
5.5
0.5 – 6
HD-tACS (Alpha, 10 Hz)
11.8
9.575 – 13.25
Personalized Beta-Gamma tACS
7.5
5.5 – 8
3 Month
Group
Value
95% CI
HD-tDCS
2.6
1.5 – 3.5
HD-tACS (Alpha, 10 Hz)
7.5
5 – 9.625
Personalized Beta-Gamma tACS
2
0.5 – 7
Altman Self-Rating Mania Scale (ASRM)Primary· Change from baseline to 5 Day follow-up
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Baseline
Group
Value
95% CI
HD-tDCS
5
4 – 5
HD-tACS (Alpha, 10 Hz)
7
3.75 – 9.5
Personalized Beta-Gamma tACS
3
3 – 5
Day 5
Group
Value
95% CI
HD-tDCS
7
4 – 8
HD-tACS (Alpha, 10 Hz)
2
1 – 4.25
Personalized Beta-Gamma tACS
5
5 – 7
Altman Self-Rating Mania Scale (ASRM)Primary· Change from baseline to 1-month follow-up
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Baseline
Group
Value
95% CI
HD-tDCS
5
4 – 5
HD-tACS (Alpha, 10 Hz)
7
3.75 – 9.5
Personalized Beta-Gamma tACS
3
3 – 5
1 Month
Group
Value
95% CI
HD-tDCS
2
1 – 3
HD-tACS (Alpha, 10 Hz)
4
2.25 – 6.25
Personalized Beta-Gamma tACS
5
5 – 6
Altman Self-Rating Mania Scale (ASRM)Primary· Change from baseline to 3-month follow-up
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Baseline
Group
Value
95% CI
HD-tDCS
5
4 – 5
HD-tACS (Alpha, 10 Hz)
7
3.75 – 9.5
Personalized Beta-Gamma tACS
3
3 – 5
3 Month
Group
Value
95% CI
HD-tDCS
2
2 – 4
HD-tACS (Alpha, 10 Hz)
3.6
2.25 – 4.5
Personalized Beta-Gamma tACS
6
5 – 7.2
Psychiatric Hospitalizations for Mania Post Study EntryPrimary· Cumulative count of hospitalizations for mania from baseline to end of study
Psychiatric hospitalization for mania. Count of hospitalizations from baseline to end of study period assessed at Day 5, 1 Month \& 3 Month.
Baseline
Group
Value
95% CI
HD-tDCS
0
HD-tACS (Alpha, 10 Hz)
0
Personalized Beta-Gamma tACS
0
Day 5
Group
Value
95% CI
HD-tDCS
0
HD-tACS (Alpha, 10 Hz)
0
Personalized Beta-Gamma tACS
0
1 Month
Group
Value
95% CI
HD-tDCS
0
HD-tACS (Alpha, 10 Hz)
1
Personalized Beta-Gamma tACS
0
3 Month
Group
Value
95% CI
HD-tDCS
0
HD-tACS (Alpha, 10 Hz)
0
Personalized Beta-Gamma tACS
0
Balloon Analogue Risk Task (BART)Secondary· Change from baseline to 5 Day follow-up
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Baseline
Group
Value
95% CI
HD-tDCS
16
10 – 17
HD-tACS (Alpha, 10 Hz)
13.5
11.5 – 15.25
Personalized Beta-Gamma tACS
13
11 – 19
Day 5
Group
Value
95% CI
HD-tDCS
17
16 – 17
HD-tACS (Alpha, 10 Hz)
13.5
7.75 – 20
Personalized Beta-Gamma tACS
18
14 – 25
Balloon Analogue Risk Task (BART)Secondary· Change from baseline to 1-month follow-up
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Baseline
Group
Value
95% CI
HD-tDCS
16
10 – 17
HD-tACS (Alpha, 10 Hz)
13.5
11.5 – 15.25
Personalized Beta-Gamma tACS
13
11 – 19
1 Month
Group
Value
95% CI
HD-tDCS
15
15 – 16
HD-tACS (Alpha, 10 Hz)
14.1
10.5 – 18.65
Personalized Beta-Gamma tACS
27
17 – 28
Balloon Analogue Risk Task (BART)Secondary· Change from baseline to 3-month follow-up
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Baseline
Group
Value
95% CI
HD-tDCS
16
10 – 17
HD-tACS (Alpha, 10 Hz)
13.5
11.5 – 15.25
Personalized Beta-Gamma tACS
13
11 – 19
3 Month
Group
Value
95% CI
HD-tDCS
12.2
11 – 14
HD-tACS (Alpha, 10 Hz)
14.7
11.75 – 18.3
Personalized Beta-Gamma tACS
18
14 – 22
The Go/No Go TaskSecondary· Change from baseline to 5 Day follow-up
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Baseline
Group
Value
95% CI
HD-tDCS
876.9768638
675.4974359 – 923.1895604
HD-tACS (Alpha, 10 Hz)
954.3716154
894.5683204 – 964.7482317
Personalized Beta-Gamma tACS
859.6685714
857.6372796 – 1139.709184
Day 5
Group
Value
95% CI
HD-tDCS
927.1679389
925.6649616 – 1011.031746
HD-tACS (Alpha, 10 Hz)
878.0193364
871.9321033 – 915.1828861
Personalized Beta-Gamma tACS
917.7871795
805.0713097 – 994.2446809
The Go/No Go TaskSecondary· Change from baseline to 1-month follow-up
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Baseline
Group
Value
95% CI
HD-tDCS
876.9768638
675.4974359 – 923.1895604
HD-tACS (Alpha, 10 Hz)
954.3716154
894.5683204 – 964.7482317
Personalized Beta-Gamma tACS
859.6685714
857.6372796 – 1139.709184
1 Month
Group
Value
95% CI
HD-tDCS
923.5850515
914.8220551 – 939.1815857
HD-tACS (Alpha, 10 Hz)
919.8986144
910.2266457 – 942.2465073
Personalized Beta-Gamma tACS
880.3450882
838.5765306 – 993.5419847
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected up to 3 months after tES treatment (10 sessions over 1 week) was completed..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Mania is a core symptom of bipolar disorder involving periods of euphoria. Decreased inhibitory control, increased risk-taking behaviors, and aberrant reward processing are some of the more recognized symptoms of bipolar disorder and are included in the diagnostic criteria for mania. Current drug therapies for mania are frequently intolerable, ineffective, and carry significant risk for side effects. Presently there are no neurobiologically informed therapies that treat or prevent mania. However, using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of mania in people without a psychiatric history can occur in different brain locations, such as the right orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right inferior temporal gyrus (ITG). This lesion network evidence converges with existing cross-sectional and longitudinal observations in bipolar mania that have identified specific disruptions in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior, and reward learning which are major components of bipolar mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward processing suggests that this region could be targeted using non-invasive brain stimulation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Beth Israel Deaconess Medical Center
Last refreshed: 6 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05445466.