Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation (Alpha-MOD)

Sebastian Olbrich

Status: Not yet enrolling

Conditions: Suicidal Ideation Active; Depression Disorders

Treatments: Procedure: Sham alpha-tACS; Procedure: alpha-tACS

Study type: Interventional

Funder types: Other

Identifiers

NCT06832124

2024-02027

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Sham tACS

Sham Comparator group

Description:

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).

Treatment:

Procedure: Sham alpha-tACS

Active tACS

Experimental group

Description:

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.

Treatment:

Procedure: alpha-tACS