Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sham alpha-tACS, alpha-tACS.
- Who it may be relevant to
- Registry conditions: Suicidal Ideation Active, Depression Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Modulating Alpha-connectivity in Patients with Active Suicidal Ideation Using Transcranial Alternating Current Stimulation
Overview
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.
Interventions
- Procedure Sham alpha-tACS
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). - Procedure alpha-tACS
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
Primary outcome measures
- EEG alpha functional connectivity (phase synchronization) [Time frame: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)]
- Response style questionnaire (RSQ-10D) [Time frame: Visit 2 to visit 3 (24 hours)]
Secondary outcome measures (10)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 37562347
Identifiers
NCT: NCT06832124 · 2024-02027