NCT05932706

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Transcranial Alternating Current Stimulation
• Depressive Disorder

Interventions

Type	Name	Description
DEVICE	High definition transcranial alternating current stimulation	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.
DEVICE	sham high definition transcranial alternating current stimulation	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2023-07-06
• Last updated: 2026-01-21

Locations

1 site across 1 country: China