Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation

NCT ID: NCT06832124

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

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.

Conditions

Suicidal Ideation Active; Depression Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham tACS

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).

Group Type: SHAM_COMPARATOR

Sham alpha-tACS

Intervention Type: PROCEDURE

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).

Active tACS

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.

Group Type: EXPERIMENTAL

alpha-tACS

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sebastian Olbrich

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Olbrich

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sebastian Olbrich, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Adult Psychiatry and Psychotherapy, University Hospital of Psychiatry Zurich, University of Zurich, Zurich, Switzerland

Central Contacts

Anna Monn, M.Sc.

Role: CONTACT

anna.monn@uzh.ch

0041 58 384 34 82

References

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.

Reference Type: BACKGROUND

PMID: 37562347 (View on PubMed)

Related Links

https://doi.org/10.17605/OSF.IO/B42J6

OSF Preregistration

Other Identifiers

2024-02027

Identifier Type: -

Identifier Source: org_study_id