Suicidal Ideation ActiveAlpha-MODNCT06832124
Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation
A study testing alpha-tACS in people with Suicidal Ideation Active and Depression Disorders, run by Sebastian Olbrich.
Trial summary
The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation Active, Depression Disorders
- What is being tested?
- alpha-tACS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active suicidal ideation defined by a score ≥3 on item #10 of the Montgomery-Asberg Depression Rating Scale (MADRS) and a combined score of ≥2 on items #4 + #5 of the Beck Scale for Suicide Ideation (BSS)
- Clinical diagnosis of a mild to severe depressive episode without psychotic symptoms
- Voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater Zurich area
- Aged 18-65 years
- Fluent in German
- Ability to give written informed consent
Who cannot join
- Mental disorders due to known physiological conditions
- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
- Intellectual disabilities
- Concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide
- Pregnancy or breast-feeding
- Chronic migraines
- Metal implants or any other factor that - in the investigators' judgment - would unduly affect patient safety or compliance during this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Modulating Alpha-connectivity in Patients with Active Suicidal Ideation Using Transcranial Alternating Current Stimulation
The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression.
The main questions it aims to answer are:
Read more
- Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation?
- Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation?
- Does personalized tACS stimulation of the DMN lead to a reduction of DMN alpha connectivity?
Researchers will compare active tACS stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and DMN alpha connectivity.
Participants will:
- Receive either active or sham tACS stimulation during stimulation sessions, but all participants will receive active tACS at least once.
- Complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation.
- Undergo EEG recordings to assess changes in DMN alpha connectivity.
This clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in August 2025.
- Conditions
- Suicidal Ideation Active, Depression Disorders
- Being tested
- Sham alpha-tACS, alpha-tACS
- Keywords
- tACS, Suicidal ideation, Rumination, Entrapment, Depression, Non-invasive brain stimulation, Suicidal thoughts and behavior
- Medical subject headings
- Suicidal Ideation, Rumination Syndrome, Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham alpha-tACSProcedure or surgery
A sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with in-phase stimulation at parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. The stimulation will involve a 10s ramp-up, followed by an immediate 10s ramp-down (no stimulation afterwards).
alpha-tACSProcedure or surgery
Active tACS with a sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with a 10s ramp-up and 10s ramp-down after stimulation. In-phase stimulation will be applied to parieto-occipital brain areas and anti-phase stimulation will be applied to frontal brain areas
| Study group | Role | What they receive |
|---|---|---|
| Sham tACS | Sham comparator | Participants assigned to this arm will receive active stimulation during one of the stimulation visits and sham stimulation for the remaining one. Sham will involve 10s ramp-up with the same stimulation protocol as the active one, followed by an immediate 10s ramp-down (no stimulation afterwards). Receives: Procedure: Sham alpha-tACS |
| Active tACS | Experimental | Participants will receive active tACS during all stimulation visits. The stimulation frequency will be adjusted to the individual alpha peak frequency with in-phase stimulation in parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. Receives: Procedure: alpha-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG alpha functional connectivity (phase synchronization)
The primary outcome measure will be changes in EEG alpha functional connectivity between pre- and post-stimulation at visit 2 (stimulation visit 1) in the active versus sham group (between-person comparison).
EEG alpha functional connectivity will also be assessed at visit 4 (stimulation visit 2). Allowing for between- and within-person comparisons as secondary outcomes.
Measured: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)
Response style questionnaire (RSQ-10D)
The primary outcome will be changes in rumination between visit 2 (pre-stimulation) and visit 3 (24 hours post-stimulation) in the active versus sham group (between-person comparison).
Rumination will also be assessed at visit 4 and visit 5, allowing for between- and within-person comparisons as secondary outcome measures.
The RSQ-10D measures two facets of rumination: brooding and reflection with 5 items each. Scores per facet range from 5 to 20 with higher scores indicating higher rumination.
Measured: Visit 2 to visit 3 (24 hours)
Secondary outcomes (10)
Beck Scale for Suicide Ideation (BSS)
Changes in suicidal ideation between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons.
The BSS is a 19-item scale measuring suicidal ideation, with two additional items assessing a history of suicide attempts. Scores range from 0 to 38 with higher scores indicating higher severity of suicidal ideation.
Measured: Visits 2-5 (24 hours)
Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
Changes in risk for suicide between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons.
The CGI-SR-I is a single-item clinician rating scale where 1 indicates "no imminent suicide risk" and 7 indicates "extreme imminent suicide risk"
Measured: Visits 2-5 (24 hours)
Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
Changes in risk for suicide between pre-stimulation at visit 2 and visit 4 and post-stimulation at visit 2 and visit 4, between- and within-person comparisons.
The CGI-SR-I is a single-item clinician rating scale where 1 indicates "no imminent suicide risk" and 7 indicates "extreme imminent suicide risk"
Measured: Visits 2 & 4 (up to 1 hour)
Clinical Global Impression of Suicidality (CGI-SS-R)
Changes in risk for suicide between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons.
The CGI-SS-R is a single-item clinician rating scale where 1 indicates "normal, not at all suicidal" and 7 indicates "among the most extremely suicidal patients"
Measured: Visits 2-5 (24 hours)
Clinical Global Impression of Suicidality (CGI-SS-R)
Changes in risk for suicide between pre-stimulation at visit 2 and visit 4 and post-stimulation at visit 2 and visit 4, between- and within-person comparisons.
The CGI-SS-R is a single-item clinician rating scale where 1 indicates "normal, not at all suicidal" and 7 indicates "among the most extremely suicidal patients"
Measured: Visits 2 & 4 (up to 1 hour)
Suicidal Intent Visual Analogue Scale (S-VAS)
Changes in suicidal intent between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons.
The S-VAS is a single-item visual analogue scale. Scores range from 0 to 100 with 0 indicating "no urge to kill myself" and 100 indicating "extreme urge to kill myself"
Measured: Visits 2-5 (24 hours)
Suicidal Intent Visual Analogue Scale (S-VAS)
Changes in suicidal intent between pre-stimulation at visit 2 and visit 4 and post-stimulation at visit 2 and visit 4, between- and within-person comparisons.
Scores range from 0 to 100 with 0 indicating "no urge to kill myself" and 100 indicating "extreme urge to kill myself".
Measured: Visits 2 & 4 (up to 1 hour)
Short Defeat and Entrapment Scale (SDES)
Changes in defeat and entrapment between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons. The SDES is an 8-item scale measuring defeat and entrapment with 4 items each. Scores range from 0 to 16 per facet (i.e., defeat/entrapment) with higher scores indicating higher defeat and entrapment, respectively.
Measured: Visits 2-5 (24 hours)
Beck Depression Inventory (BDI-II)
Changes in depressive symptoms between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons. The BDI is a 21-item scale measuring depressive symptoms. Sum scores range from 0 to 63 with higher scores indicating higher severity of depressive symptoms.
Measured: Visits 2-5 (24 hours)
Montgomery-Asberg Depression Rating Scale (MADRS)
Changes in depressive symptoms between pre-stimulation (visit 2 and visit 4) and post-stimulation (visit 3 and visit 5), between- and within-person comparisons. The MADRS is a10-item clinician rating scale measuring depressive symptoms. Scores range from 0 to 60 with higher scores indicating higher severity of depressive symptoms.
Measured: Visits 2-5 (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal Ideation ActiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sebastian Olbrich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sebastian Olbrich, University of Zurich
- Investigators
- Sebastian Olbrich, Prof. Dr. med., Principal investigator, Department of Adult Psychiatry and Psychotherapy, University Hospital of Psychiatry Zurich, University of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832124
- Sponsor's protocol ID
- 2024-02027
- Acronym
- Alpha-MOD
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical considerations and to protect the privacy of study participants, access to data will only be granted following justified requests for research purposes. Deidentified participant data and a data dictionary will then be made available to the requesting person or institution.
Publications
Bankwitz A, Ruesch A, Adank A, Hormann C, Villar de Araujo T, Schoretsanitis G, Kleim B, Olbrich S. EEG source functional connectivity in patients after a recent suicide attempt. Clin Neurophysiol. 2023 Oct;154:60-69. doi: 10.1016/j.clinph.2023.06.025. Epub 2023 Jul 22.
PubMed 37562347
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Alpha-connectivity in Patients with Active Suicidal Ideation Using Transcranial Alternating Current Stimulation
- ClinicalTrials.gov ID
- NCT06832124
- Acronym / sponsor ID
- Alpha-MOD / 2024-02027
- Conditions
- Suicidal Ideation Active, Depression Disorders
- Keywords
- tACS, Suicidal ideation, Rumination, Entrapment, Depression, Non-invasive brain stimulation, Suicidal thoughts and behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sebastian OlbrichUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression.
The main questions it aims to answer are:
- Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation?
- Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation?
- Does personalized tACS stimulation of the DMN lead to a reduction of DMN alpha connectivity?
Researchers will compare active tACS stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and DMN alpha connectivity.
Participants will:
- Receive either active or sham tACS stimulation during stimulation sessions, but all participants will receive active tACS at least once.
- Complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation.
- Undergo EEG recordings to assess changes in DMN alpha connectivity.
This clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in August 2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tACS | Sham comparator | Procedure: Sham alpha-tACSParticipants assigned to this arm will receive active stimulation during one of the stimulation visits and sham stimulation for the remaining one. Sham will involve 10s ramp-up with the same stimulation protocol as the active one, followed by an immediate 10s ramp-down (no stimulation afterwards). |
| Active tACS | Experimental | Procedure: alpha-tACSParticipants will receive active tACS during all stimulation visits. The stimulation frequency will be adjusted to the individual alpha peak frequency with in-phase stimulation in parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active suicidal ideation defined by a score ≥3 on item #10 of the Montgomery-Asberg Depression Rating Scale (MADRS) and a combined score of ≥2 on items #4 + #5 of the Beck Scale for Suicide Ideation (BSS)
- Clinical diagnosis of a mild to severe depressive episode without psychotic symptoms
- Voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater Zurich area
- Aged 18-65 years
- Fluent in German
Key exclusion criteria (7 listed)
- Mental disorders due to known physiological conditions
- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
- Intellectual disabilities
- Concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham alpha-tACSA sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with in-phase stimulation at parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. The stimulation will involve a 10s ramp-up, followed by an immediate 10s ramp-down (no stimulation afterwards). | Procedure or surgery | Sham tACS |
| alpha-tACSActive tACS with a sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with a 10s ramp-up and 10s ramp-down after stimulation. In-phase stimulation will be applied to parieto-occipital brain areas and anti-phase stimulation will be applied to frontal brain areas | Procedure or surgery | Active tACS |
Primary outcome
EEG alpha functional connectivity (phase synchronization)
Time frame: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)
The primary outcome measure will be changes in EEG alpha functional connectivity between pre- and post-stimulation at visit 2 (stimulation visit 1) in the active versus sham group (between-person comparison). EEG alpha functional connectivity will also be assessed at visit 4 (stimulation visit 2). Allowing for between- and within-person comparisons as secondary outcomes.
Response style questionnaire (RSQ-10D)
Time frame: Visit 2 to visit 3 (24 hours)
The primary outcome will be changes in rumination between visit 2 (pre-stimulation) and visit 3 (24 hours post-stimulation) in the active versus sham group (between-person comparison). Rumination will also be assessed at visit 4 and visit 5, allowing for between- and within-person comparisons as secondary outcome measures. The RSQ-10D measures two facets of rumination: brooding and reflection with 5 items each. Scores per facet range from 5 to 20 with higher scores indicating higher rumination.
10 secondary outcomes
Beck Scale for Suicide Ideation (BSS)
Time frame: Visits 2-5 (24 hours)
Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
Time frame: Visits 2-5 (24 hours)
Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
Time frame: Visits 2 & 4 (up to 1 hour)
Clinical Global Impression of Suicidality (CGI-SS-R)
Time frame: Visits 2-5 (24 hours)
Clinical Global Impression of Suicidality (CGI-SS-R)
Time frame: Visits 2 & 4 (up to 1 hour)
Suicidal Intent Visual Analogue Scale (S-VAS)
Time frame: Visits 2-5 (24 hours)
Suicidal Intent Visual Analogue Scale (S-VAS)
Time frame: Visits 2 & 4 (up to 1 hour)
Short Defeat and Entrapment Scale (SDES)
Time frame: Visits 2-5 (24 hours)
Beck Depression Inventory (BDI-II)
Time frame: Visits 2-5 (24 hours)
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Visits 2-5 (24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 37562347Bankwitz A, Ruesch A, Adank A, Hormann C, Villar de Araujo T, Schoretsanitis G, Kleim B, Olbrich S. EEG source functional connectivity in patients after a recent suicide attempt. Clin Neurophysiol. 2023 Oct;154:60-69. doi: 10.1016/j.clinph.2023.06.025. Epub 2023 Jul 22.
- OSF PreregistrationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to ethical considerations and to protect the privacy of study participants, access to data will only be granted following justified requests for research purposes. Deidentified participant data and a data dictionary will then be made available to the requesting person or institution.
Related trials for Suicidal Ideation Active
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
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The Group Risk Reduction Intervention Therapy (GRRIT) Project
Suicidal Ideation, Suicide, Attempted
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Olbrich, Prof. Dr. med. principal investigator
Department of Adult Psychiatry and Psychotherapy, University Hospital of Psychiatry Zurich, University of Zurich, Zurich, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing alpha-tACS in people with Suicidal Ideation Active and Depression Disorders, run by Sebastian Olbrich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Monn, M.Sc. (0041 58 384 34 82, anna.monn@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG alpha functional connectivity (phase synchronization) (time frame: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06832124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.