Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder

NCT05932706 | Completed

• 1 other identifier: AHMU-tACS-MDD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the intervention effect of high definition transcranial alternating current stimulation (HD-tACS) on suicidal ideation in patients with depressive disorder and its underlying neural mechanism by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Conditions

Transcranial Alternating Current Stimulation; Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Beck Scale for Suicide Ideation (BSS) Score

  The BSS is a 19-item scale to measure the severity of suicidal ideation, where each item is rated on a scale from 0 to 2. The BSS total score ranges from 0 to 38 with lower scores indicating less suicidal ideation.

  baseline, week 1 (end of treatment), and week 5 (end of follow-up)

Secondary Outcomes (9)

• Beck Scale for Suicide Ideation (BSS) Response Rate (≥50% Improvement From Baseline)

  week 1 (end of treatment) and week 5 (end of follow-up)

• Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score

  baseline, week 1 (end of treatment), and week 5 (end of follow-up)

• Change in Hamilton Depression Rating Scale (HAMD) Score

  baseline, week 1 (end of treatment), and week 5 (end of follow-up)

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

  baseline, week 1 (end of treatment), and week 5 (end of follow-up)

• Change in Beck Depression Inventory (BDI) Score

  baseline, week 1 (end of treatment), and week 5 (end of follow-up)

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

The central electrode was placed over F3, with return electrodes at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 30 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as IAF.

Device: High definition transcranial alternating current stimulation

sham stimulation

SHAM COMPARATOR

In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 30-minute intervention. Participants will receive sham tACS twice daily for two weeks.

Device: sham high definition transcranial alternating current stimulation

Interventions

High definition transcranial alternating current stimulation DEVICE

tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.

real stimulation

sham high definition transcranial alternating current stimulation DEVICE

In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15s and 15s); no current was delivered during the 30-minute intervention.

sham stimulation

Eligibility Criteria

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

You may qualify if:

• the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and item 3 of the HAMD≥3.
• the age ranged from 18 to 65 years old, and the length of education was more than 5 years.
• the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

You may not qualify if:

• accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
• accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
• accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Yanghua Tian

Hefei, Anhui, 230022, China

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Yanghua Tian, PhD

  Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department, Anhui Medical University

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: July 6, 2023
• Study Start: September 1, 2022
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: January 21, 2026

Record last verified: 2023-06

Locations

CN (1)