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

Efficacy and Mechanisms of Personalized tACS Targeting Anhedonia in Late-Life Depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07637773
Enrollment
80
Registered
2026-06-10
Start date
2026-03-16
Completion date
2027-12-31
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anhedonia, Late-Life Depression

Keywords

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

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.

Detailed description

This project aims to explore effective treatment strategies and mechanisms of action for personalized transcranial alternating current stimulation (tACS) targeting anhedonia in late-life depression (LLD). Late-life depression has a high prevalence, with 70% of patients exhibiting symptoms of anhedonia, which is . Current pharmacological treatments face challenges such as poor response rates and significant side effects, creating an urgent need for novel intervention strategies. As a non-invasive neurostimulation technique, tACS can improve depressive symptoms by modulating brain oscillatory activity; however, personalized treatment protocols and mechanisms specifically targeting anhedonia in LLD remain unclear. By optimizing tACS parameters, validating clinical efficacy, and elucidating the underlying neural mechanisms, this project will fill a research gap in this field. The findings will not only provide safe and effective non-pharmacological treatment options for patients with geriatric depression, thereby reducing suicide risk, but will also advance the application of tACS technology in precision medicine for mental disorders, holding significant clinical value and social implications.

Interventions

DEVICETranscranial Alternating Current Stimulation (tACS)

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

DEVICEshame tACS

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.

Sponsors

Jie Li
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (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

Exclusion criteria

\- (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.

Design outcomes

Primary

MeasureTime frameDescription
Dimensional Anhedonia Rating Scale (DARS)12 weekThe Dimensional Anhedonia Rating Scale (DARS) assesses the degree of anhedonia in patients.

Secondary

MeasureTime frameDescription
Hamilton Depression Scale,HAMD -1712 weekThe 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.

Countries

China

Contacts

CONTACTDaliang Sun Da liang Sun, Doctor
474929588@qq.com+86 88188876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026