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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorJie Li

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Alternating Current Stimulation (tACS)

    Device

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

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: activeActive comparator 1 intervention
Group B: shameSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dimensional Anhedonia Rating Scale (DARS)

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

Time frame
12 week

Secondary outcomes

1

Hamilton Depression Scale,HAMD -17

The severity of a patient's depressive symptoms is assessed using the Hamilton Depression Scale (HAMD)-17. This scale consists of 17 items that comprehensively evaluate a patient's depressive symptoms; the higher the score, the more severe the depressive symptoms.

Time frame
12 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jie Li

Lead sponsor

Tianjin Anding Hospital

Sponsor institution