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

Last updated: June 27, 2023
Sponsor: Anhui Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

sham high definition transcranial alternating current stimulation

High definition transcranial alternating current stimulation

Clinical Study ID

NCT05932706
AHMU-tACS-MDD
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • the patients were diagnosed by more than 2 psychiatrists and met the diagnosticcriteria of DSM-5 for depression, and HAMD>17, BSS>6, PHQ-15>5.
  • the age ranged from 18 to 65 years old, and the length of education was more than 5years.
  • the visual acuity or corrected visual acuity is normal, right-handed, can cooperatewith the completion of various experimental tests.

Exclusion

Exclusion Criteria:

  • accompanied by severe somatic diseases, such as severe heart, liver, renalinsufficiency 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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: sham high definition transcranial alternating current stimulation
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2024

Study Description

Forty patients with depressive disorder diagnosed by DSM-5 were recruited from the Anhui Mental Health Center and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving high definition transcranial alternating current stimulation (HD-tACS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), electroencephalography (EEG), and HD-tACS treatment conducted by trained researchers at the Anhui Mental Health Center. All the participants were randomized (1:1) to receive an "active HD-tACS" or "sham HD-tACS" treatment protocol. tACS: the central electrode was placed over F3 with return electrodes placed 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 individual alpha frequency (IAF). Sham HD-tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 15 and 15 seconds.

Before and after the treatments, the patients received a battery measure of neuropsychological tests, resting EEG, and MRI scans in multimodalities. The neuropsychological assessment included HAMD, MADRS, BDI, HAMA, BSS, C-SSRS, PHQ15, RRS, TEPS, PVAQ, MoCA, Stroop Test, VFT, DST, and AVLT. Multimodal MRI includes 3D-T1, rs-fMRI, and DTI. The symptoms of the patients were followed up one and two months after the end of treatments.

Connect with a study center

  • Yanghua Tian

    Hefei, Anhui 230022
    China

    Active - Recruiting

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