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Depression Disorder / alpha-tACS / tDCS · Interventional Study
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned randomized controlled trial comparing transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) against sham in patients with comorbid major depressive disorder and chronic pain. No efficacy results have been posted; the registry describes study design, planned interventions, and outcomes only. Readers should expect preliminary data once recruitment completes and follow-up assessments are conducted.
Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Depression Disorder, Chronic Pain; age from 18 Years; to 80 Years. Intervention: tDCS; alpha-tACS; Exploratory Open-Label tACS Group. Compared with: Sham — Sham Comparator. n = 160. 2 sites: China.
This is a planned randomized controlled trial comparing transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) against sham in patients with comorbid major depressive disorder and chronic pain. No efficacy results have been posted; the registry describes study design, planned interventions, and outcomes only. Readers should expect preliminary data once recruitment completes and follow-up assessments are conducted.
Efficacy, safety, and effect sizes are not reported and cannot be inferred from registration data.
No clinical impact can be assessed from this registry record, as no efficacy data have been reported. Clinicians should monitor for publication of results when the trial concludes to determine whether tACS or tDCS offers benefit for comorbid depression and chronic pain.
This is a clinical trial registry record for a recruiting study with no posted results; it describes planned design and methods only, representing early-phase evidence generation rather than evidence of efficacy.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no efficacy data have been reported. Clinicians should monitor for publication of results when the trial concludes to determine whether tACS or tDCS offers benefit for comorbid depression and chronic pain.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07334561). This is a study registration, not published results. Lead sponsor: Shanghai Mental Health Center. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 160 participants (ESTIMATED). Conditions: Depression Disorder, Chronic Pain. Interventions: DEVICE: tDCS; DEVICE: alpha-tACS; DEVICE: Sham. Primary outcome measures: Proportion of Participants Achieving MCID on BPI Pain Intensity Subscale , At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline. Brief summary: The goal of this clinical trial is to learn if active transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) can improve pain symptoms in patients with major depressive disorder (MDD) and chronic pain symptoms. It will also explore the neural mechanisms underlying these potential effects. The main questions it aims to answer are: 1. Are there any differences in the overall efficacy among the three intervention groups (tACS, tDCS, and sham)? 2. Is active tACS superior to sham stimulation in reducing pain symptoms in patients with MDD and chronic pain over the 2-week treatment period and at the 6-week follow-up? 3. Is active tACS superior to active tDCS in reducing pain symptoms? 4. Does active tACS, compared to tDCS, demonstrate a more persistent improvement in pain symptoms, as measured at the 6-week follow-up? 5. As an exploratory objective, what neural oscillation entrainment mechanisms underlie the potential analgesic effects of tACS? Researchers will compare three parallel groups: active tACS, active tDCS, and sham stimulation, to evaluate their efficacy. All three groups are randomized and double-blinded. In addition, a separate exploratory open-label cohort of 10 participants will receive the same active tACS intervention while performing a cognitive task. This exploratory arm is designed to investigate the neural oscillation entrainment effects of tACS. Data from this arm will be analyzed separately and are not included in the primary confirmatory analyses. Participants in the main randomized trial will: 1. Receive 40 minutes of stimulation (tACS, tDCS, or sham) once daily, 5 days per week, for 2 weeks (10 sessions total). 2. Complete clinical assessments and cognitive tests at baseline, mid-intervention (week 1), post-intervention (week 2), and at a 6-week follow-up. 3. Undergo resting-state functional MRI (rs-fMRI) and blood sample collection at baseline and post-intervention for exploratory biomarker analyses. Participants in the exploratory open-label arm will: 1. Receive active tACS (1 mA, 10 Hz, 40 minutes) once daily, 5 days per week, for 2 weeks (10 sessions total), while performing a cognitive task during stimulation. 2. Complete resting-state and task-state EEG recordings at the following time points: (1) At baseline (pre-intervention) (2) Immediately before and after the 1st tACS session (3) Immediately before and after the 10th tACS session (4) On the day after completion of all 10 sessions These EEG recordings are designed to assess: (1) the immediate entrainment effects of a single tACS session, (2) the cumulative effects after repeated tACS sessions, and (3) the persistent neural plasticity changes following the full intervention course.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.