Transcranial Electrical Stimulation for Comorbid Depression and Chronic Pain

Sponsor
Shanghai Mental Health Center
Study ID
NCT07334561
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Depression Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dual-target a-tDCS UHCDS — DEVICE
    Participants receive active anodal transcranial direct current stimulation (tDCS) delivered via a unilateral hemispheric concurrent dual-site stimulation (UHCDS) montage. Two anodal electrodes (5 × 5 cm) are placed over the left dorsolateral prefrontal cortex (DLPFC, F3) and the left primary motor cortex (M1, C3), with a common cathodal reference electrode (5 × 7 cm) placed over the contralateral supraorbital area (Fp2). A constant current of 2 mA is applied for 20 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
  • Single-target a-tDCS — DEVICE
    Participants receive active single-target anodal transcranial direct current stimulation (tDCS). The anodal electrode (5 × 5 cm) is placed over the left dorsolateral prefrontal cortex (DLPFC, F3), and the cathodal electrode (5 × 7 cm) is placed over the contralateral supraorbital area (Fp2). A constant current of 2 mA is applied for 20 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
  • 10 Hz alpha-tACS — DEVICE
    Participants receive active 10 Hz transcranial alternating current stimulation (tACS). Three 5 × 5 cm electrodes are placed as follows: target electrode over F3, counter electrode over F4, and reference electrode over Cz. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied with the following intensity parameters: 1 mA (zero-to-peak) at F3 and F4 electrodes, and 2 mA (zero-to-peak) at the Cz reference electrode. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).
  • Sham tES — DEVICE
    Participants receive sham transcranial electrical stimulation (tES) using the same electrode montage as the corresponding active groups. To maintain blinding, the stimulator delivers current only during the initial 30-second ramp-up period, followed by an immediate ramp-down, and a final 30-second ramp-up at the end of the stimulation session. This mimics the initial sensation of active stimulation without delivering sufficient current to induce neural modulation. For the tACS sham condition, the 40-minute session includes only the ramp-up/ramp-down sequences at the beginning and end. Participants are randomly assigned to one of the three sham montages (dual-target tDCS, single-target tDCS, or tACS) in parallel with the active groups.

Study Details

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.

Key Dates

First listed
Jan 12, 2026
Start date
May 31, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dual-target a-tDCS UHCDS
    Participants receive active anodal transcranial direct current stimulation (tDCS) delivered via a unilateral hemispheric concurrent dual-site stimulation (UHCDS) montage. Two anodal electrodes are placed over the left dorsolateral prefrontal cortex (DLPFC, F3) and the left primary motor cortex (M1, C3), with a common cathodal reference electrode placed over the contralateral supraorbital area (Fp2). A constant current of 2 mA is applied for 20 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
  • Experimental: Single-target a-tDCS
    Participants receive active single-target anodal transcranial direct current stimulation (tDCS). The anodal electrode is placed over the left dorsolateral prefrontal cortex (DLPFC, F3), and the cathodal electrode is placed over the contralateral supraorbital area (Fp2). A constant current of 2 mA is applied for 20 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
  • Experimental: 10 Hz alpha-tACS
    Participants receive active 10 Hz transcranial alternating current stimulation (tACS). Three 5 × 5 cm electrodes are placed as follows: target electrode over F3, counter electrode over F4, and reference electrode over Cz. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied with the following intensity parameters: 1 mA (zero-to-peak) at F3 and F4 electrodes, and 2 mA (zero-to-peak) at the Cz reference electrode. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).
  • Sham Comparator: Sham tES
    Participants receive sham transcranial electrical stimulation (tES) using the same electrode montage as the corresponding active groups. To maintain blinding, the stimulator delivers current only during the initial 30-second ramp-up period, followed by an immediate ramp-down, and a final 30-second ramp-up at the end of the stimulation session. This mimics the initial sensation of active stimulation without delivering sufficient current to induce neural modulation. For the tACS sham condition, the 40-minute session includes only the ramp-up/ramp-down sequences at the beginning and end. Participants are randomly assigned to one of the three sham montages (dual-target tDCS, single-target tDCS, or tACS) in parallel with the active groups.

Primary Outcome Measure

Brief Pain Inventory (BPI) - Pain Intensity Subscale [ Time Frame: Baseline, 1 week, 2 weeks, 6 weeks ]

Central Contacts

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