Clinical trial NCT06832124: Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation
Official title: Modulating Alpha-connectivity in Patients with Active Suicidal Ideation Using Transcranial Alternating Current Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation Active
Depression Disorders
Keywords: tACS
Suicidal ideation
Rumination
Entrapment
Depression
Non-invasive brain stimulation
Suicidal thoughts and behavior
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 depression.

The main questions it aims to answer are:

1. Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation?
2. Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation?
3. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: EEG alpha functional connectivity (phase synchronization)
timeFrame: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)
measure: Response style questionnaire (RSQ-10D)
timeFrame: Visit 2 to visit 3 (24 hours)
Secondary outcomes:
measure: Beck Scale for Suicide Ideation (BSS)
timeFrame: Visits 2-5 (24 hours)
measure: Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
timeFrame: Visits 2-5 (24 hours)
measure: Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
timeFrame: Visits 2 & 4 (up to 1 hour)
measure: Clinical Global Impression of Suicidality (CGI-SS-R)
timeFrame: Visits 2-5 (24 hours)
measure: Clinical Global Impression of Suicidality (CGI-SS-R)
timeFrame: Visits 2 & 4 (up to 1 hour)
measure: Suicidal Intent Visual Analogue Scale (S-VAS)
timeFrame: Visits 2-5 (24 hours)
measure: Suicidal Intent Visual Analogue Scale (S-VAS)
timeFrame: Visits 2 & 4 (up to 1 hour)
measure: Short Defeat and Entrapment Scale (SDES)
timeFrame: Visits 2-5 (24 hours)
measure: Beck Depression Inventory (BDI-II)
timeFrame: Visits 2-5 (24 hours)
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Visits 2-5 (24 hours)
Other outcomes:
measure: EEG alpha power
timeFrame: Visits 2 & 4 (up to 1 hour)
measure: EEG: Individual alpha peak frequency
timeFrame: Visits 2 & 4 (up to 1 hour)
measure: Beck Hopelessness Scale (BHS)
timeFrame: Visits 2-5 (24 hours)
measure: Perceived Burdensomeness Visual Analogue Scale (PB-VAS)
timeFrame: Visits 2-5 (24 hours)
measure: Perceived Burdensomeness Visual Analogue Scale (PB-VAS)
timeFrame: Visits 2 & 4 (up to 1 hour)
measure: Positive and Negative Affective Schedule (PANAS)
timeFrame: Visits 2-5 (24 hours)
Locations:
Study officials:
affiliation: Department of Adult Psychiatry and Psychotherapy, University Hospital of Psychiatry Zurich, University of Zurich, Zurich, Switzerland
name: Sebastian Olbrich, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.