Actively Recruiting
Effectiveness and Mechanisms of Transcranial Alternating Current Stimulation in Treating High-Inflammation Refractory Depression
Led by Tianjin Anding Hospital · Updated on 2025-02-06
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of transcranial alternating current stimulation (tACS) on patients with treatment-resistant depression (TRD) who also have high inflammatory activity. This 12-week randomized controlled trial involves 52 patients and aims to compare changes in depressive symptoms and biological markers after active tACS treatment versus a sham stimulation. The study also explores the potential mechanisms behind how tACS may influence depression, especially regarding immune-inflammatory responses. Participants are randomly assigned to receive either active tACS treatment or sham stimulation, each delivered 20 times over four weeks at a frequency of 77.5Hz and an intensity of 15mA. Both groups continue their existing antidepressant treatments unchanged during the study. Before and after the intervention phase, participants undergo resting-state EEG recordings and provide fasting blood samples to assess brain activity and inflammatory biomarkers. After the intervention, an 8-week follow-up period includes additional assessments at weeks 8 and 12. Throughout the trial, participants complete multiple evaluations using the HAMD-17 depression scale at baseline, during treatment, and follow-up visits. Blood samples and EEG data are collected to analyze changes in inflammatory factors and brain wave activity. The study measures treatment effectiveness by comparing changes in depressive symptoms and biological markers between the active and sham groups. Safety is monitored by ongoing assessments, and the total study duration for participants is 12 weeks.
CONDITIONS
Brief Title
TACS on High-inflammatory and Refractory Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 55 years
- Diagnosed with depression using DSM-5 criteria by a psychiatrist
- Score of 17 or above on the 17-item Hamilton Depression Rating Scale (HAMD-17), with at least 2 points on the depression item
- C-reactive protein (CRP) level between 0.85 and 10 mg/L
- DM-TRD score of at least 12.5
- Stable use of antidepressants or antipsychotics for at least 2 weeks during the current depressive episode
- Able to understand and sign the informed consent form
You will not qualify if you...
- History of seizures, epilepsy, hydrocephalus, central nervous system tumors, or acute brain injury or infections
- Score of 3 or 4 on item 3 of the HAMD-17 or history of suicidal behavior with significant risk
- Received electroconvulsive therapy, modified ECT, TMS, tDCS, tACS, or other neuromodulation treatments within one month prior to enrollment
- Pregnant or breastfeeding women
- Severe or unstable organic disease
- Use of anti-inflammatory drugs for more than 7 days in the last 2 months or use of immunosuppressive drugs like corticosteroids
- Chronic infectious or autoimmune diseases such as lupus, enteritis, hepatitis
- History of substance dependence or abuse
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either transcranial Alternating Current Stimulation (tACS) or sham stimulation, with 20 sessions over 4 weeks while continuing their antidepressant medication. Assessments including EEG and blood collection are conducted before, during, and after the intervention.
5 visits per week for 4 weeks (in-person)
Duration - 8 weeks
Participants are monitored for 8 weeks after treatment ends with assessments of depression severity, EEG, and blood samples at weeks 8 and 12 to evaluate the durability of treatment effects.
2 visits (in-person) at weeks 8 and 12
Trial Site Locations
Total: 1 location
1
The 20th ward of general psychiatric department
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
C
Chenghao Yang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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