Transcranial Electrical Stimulation for Comorbid Depression and Chronic Pain (NCT07334561) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcranial Electrical Stimulation for Comorbid Depression and Chronic Pain
China240 participantsStarted 2026-05
Plain-language summary
This clinical trial aims to investigate a novel non-pharmacological intervention, transcranial electrical stimulation (tES), for the treatment of comorbid depression and chronic pain. The primary objectives are to optimize neurostimulation parameters through a multicenter randomized controlled design and to elucidate the underlying neural circuit-immune interaction mechanisms of this comorbidity. Participants with comorbid depression and chronic pain will be randomly assigned to receive one of four interventions: (1) anodal tDCS unilateral hemispheric concurrent dual-site stimulation (a-tDCS UHCDS) targeting the left DLPFC and M1; (2) single-target anodal tDCS over the left DLPFC; (3) 40 Hz gamma transcranial alternating current stimulation (tACS); or (4) sham stimulation. The intervention period will last for 2 weeks, followed by a series of post-treatment follow-up assessments. Researchers will compare the changes in depression severity (e.g., assessed by HAMD-17) and pain intensity (e.g., NRS, BPI) across groups to evaluate the efficacy. Secondary outcomes include pain perception, quantitative sensory testing (QST), fMRI, MEG, metabolic markers, neurotransmitter and inflammatory biomarkers. This study aims to provide a precise, individualized therapeutic strategy, reduce reliance on pharmacotherapy, and promote the development of domestic high-end medical devices.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Aged 18-65 years;
✓. Meet the diagnostic criteria for a depressive episode according to DSM-5, with current mild-to-moderate depressive symptoms (HAMD-17 score ≥8 and ≤23);
✓. Report persistent pain lasting ≥3 months and score ≥4 on item 5 of the Brief Pain Inventory (BPI);
✓. Maintain a stable anti-depression drug and psychological treatment plan (including dosage, drug type, or therapeutic approach) for at least four weeks prior to enrollment;
✓. Right-handed, with normal hearing, vision, or corrected vision;
✓. Able to voluntarily provide written informed consent to participate in the study and willing and capable of complying with all study procedures.
Exclusion criteria
✕. Diagnosed with other psychiatric disorders, including schizophrenia spectrum disorders, bipolar I disorder (due to potential risk of manic episodes and contraindication of lithium or anticonvulsants), primary anxiety disorders, depression associated with severe somatic illness, etc.
. Active suicidal ideation, defined as a score of 4 on item 3 of the HAMD-17.
✕. Severe or treatment-resistant depression (HAMD-17 score ≥23, with current depressive episode lasting at least 2 years or failure to respond to two or more antidepressant treatments during the current episode).
✕. Substance use disorder within the past 3 months.
✕. Experience of malignant pain due to cancer pain syndrome, visceral pain (e.g., gastric pain), or referred pain (e.g., back pain from pancreatitis).
✕. Having undergone neuromodulation treatments within the past 3 months, including electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial electrical stimulation (tES).
✕. Contraindications to transcranial electrical stimulation (e.g., intracranial metal implants, cardiac pacemaker, cochlear implant, skin lesions at stimulation sites, personal or family history of epilepsy).