Investigating the Efficacy and Mechanisms of Individualized tACS Targeting Anhedonia in Late-Life Depression

NCT07637773 | Recruiting DMC

• 1 other identifier: tACS-MDD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This project focuses on clinical translational research into personalized transcranial alternating current stimulation (tACS) for treating anhedonia in late-life depression (LLD). Key components include: (1) Optimizing individualized tACS treatment parameters through randomized, double-blind, controlled trials and establishing precise treatment protocols using deep learning algorithms; (2) Assessing the short-term (2 weeks) and long-term (3 months) efficacy of tACS on depressive symptoms and anhedonia using scales such as the HAMD, SHAPS, and DARS, while monitoring safety; (3) Integrating multimodal detection technologies (64-channel EEG, inflammatory factors/neurotransmitters, etc.) to elucidate the mechanisms by which tACS alleviates anhedonia through modulating prefrontal neural oscillations (y-band), improving synaptic plasticity (increased BDNF), and regulating neurotransmitters (5-HT, DA). This study will establish, for the first time, an individualized parameter system for tACS treatment of LLD, providing a novel non-pharmacological intervention strategy for clinical practice.

Conditions

Anhedonia; Late-Life Depression

Keywords

transcranial alternating current stimulation; late-life depression; anhedonia; Brain function

Outcome Measures

Primary Outcomes (1)

• Dimensional Anhedonia Rating Scale (DARS)

  The Dimensional Anhedonia Rating Scale (DARS) assesses the degree of anhedonia in patients.

  12 week

Secondary Outcomes (1)

• Hamilton Depression Scale，HAMD -17

  12 week

Study Arms (2)

active

ACTIVE COMPARATOR

The peak-to-peak amplitude was 1 mA at 40 Hz (tACS), with a frequency and a sinusoidal stimulation waveform. The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 international EEG electrode placement system, with CZ serving as the return electrode.

Device: Transcranial Alternating Current Stimulation (tACS)

shame

SHAM COMPARATOR

The peak-to-peak amplitude was 1 mA at 40 Hz (tACS), with a frequency and a sinusoidal stimulation waveform. The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 international EEG electrode placement system, with CZ serving as the return electrode, shame arm is not biologically active.

Device: shame tACS

Interventions

shame tACS DEVICE

The sham tACS group received 40 Hz tACS with a peak-to-peak amplitude of 1 mA, a frequency of y, and a sinusoidal waveform. The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 system of international EEG electrode placement, with CZ serving as the return electrode, which did not generate stimulation pulses.

shame

Transcranial Alternating Current Stimulation (tACS) DEVICE

divided into a real-stimulus group and a sham-stimulus group

active

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients were interviewed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Clinical Version (SCID-5-CV) to confirm that they met the DSM-5 diagnostic criteria for "major depressive disorder"; (2) Age ≥ 60 years; gender not restricted; (3) Hamilton Depression Scale (HAMD)-17 score \> 24

You may not qualify if:

• \- (1) History of severe head trauma or serious neurological conditions such as epilepsy; (2) Any brain devices or implants, including cochlear implants and aneurysm clips; treatments such as transcranial direct current stimulation (tDCS).
• (3) Individuals who have undergone other physical modulation therapies within the past 8 weeks, including but not limited to non-convulsive electroconvulsive therapy, repetitive transcranial magnetic stimulation, and transcranial direct current stimulation.

Sponsors & Collaborators

• Jie Li: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

MeSH Terms

Conditions

Anhedonia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Daliang Sun Da liang Sun, Doctor

CONTACT

+86 88188876; 474929588@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief psychiatrist

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 10, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)