Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation

NCT06832124 | Not Yet Recruiting

• 1 other identifier: 2024-02027
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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:

• 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

Keywords

tACS; Suicidal ideation; Rumination; Entrapment; Depression; Non-invasive brain stimulation; Suicidal thoughts and behavior

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Visit 2 to visit 3 (24 hours)

Secondary Outcomes (10)

• Beck Scale for Suicide Ideation (BSS)

  Visits 2-5 (24 hours)

• Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)

  Visits 2-5 (24 hours)

• Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)

  Visits 2 & 4 (up to 1 hour)

• Clinical Global Impression of Suicidality (CGI-SS-R)

  Visits 2-5 (24 hours)

• Clinical Global Impression of Suicidality (CGI-SS-R)

  Visits 2 & 4 (up to 1 hour)

Other Outcomes (6)

• EEG alpha power

  Visits 2 & 4 (up to 1 hour)

• EEG: Individual alpha peak frequency

  Visits 2 & 4 (up to 1 hour)

• Beck Hopelessness Scale (BHS)

  Visits 2-5 (24 hours)

Study Arms (2)

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).

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.

Procedure: alpha-tACS

Interventions

Sham alpha-tACS 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).

Sham tACS

alpha-tACS 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

Active tACS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sebastian Olbrich: lead

Related Publications (1)

• 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 BACKGROUND

Related Links

• OSF Preregistration

MeSH Terms

Conditions

Suicidal Ideation; Rumination Syndrome; Depression; Behavior

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Sebastian Olbrich, Prof. Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Monn, M.Sc.

CONTACT

0041 58 384 34 82; anna.monn@uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators assessing primary electroencephalography (EEG) outcomes will also be blinded to the assigned study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share