Multitarget Transcranial Direct Current Stimulation for Comorbid Depression and Chronic Pain: A Multicenter Randomized Controlled Trial

NCT ID: NCT07334561

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-12-31

Brief Summary

This clinical trial aims to investigate a novel non-pharmacological intervention, transcranial direct current stimulation (tDCS) for the treatment of comorbid depression and 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 active multi-target tES or 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-24) and pain intensity (e.g., NRS, BPI) across groups to evaluate the efficacy. Secondary outcomes include pain perception, quuatitive sensory test, fMRI, MEG, metabolic markers, neurotransmitter and inflammation 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.

Conditions

Depression Disorder; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tDCS-DLPFC group

They receive actual tDCS on purpose brain targets (DLPFC).

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

All the groups receive respective treatment 5 days/week for 2 weeks (10 sessions), with 2mA current, the anode on the F3, the cathode on the right supraorbital, 20min each session.

Sham Group

They receive fake tDCS (no current) on purpose brain targets.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

All the groups receive respective treatment 5 days/week for 2 weeks (10 sessions), with 2mA current only at the beginning and the end of the intervention for 30 seconds (0mA for 19min), the anode on the F3 and C3, the cathode on the right supraorbital, 20min each session.

tDCS-M1-DLPFC

They receive actual tDCS on purpose brain targets (M1+DLPFC).

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

All the groups receive respective treatment 5 days/week for 2 weeks (10 sessions), with 2mA current, the anode on the F3 and C3, the cathode on the right supraorbital, 20min each session.

Interventions

tDCS

All the groups receive respective treatment 5 days/week for 2 weeks (10 sessions), with 2mA current, the anode on the F3 and C3, the cathode on the right supraorbital, 20min each session.

Intervention Type: DEVICE

tDCS

All the groups receive respective treatment 5 days/week for 2 weeks (10 sessions), with 2mA current only at the beginning and the end of the intervention for 30 seconds (0mA for 19min), the anode on the F3 and C3, the cathode on the right supraorbital, 20min each session.

Intervention Type: DEVICE

tDCS

All the groups receive respective treatment 5 days/week for 2 weeks (10 sessions), with 2mA current, the anode on the F3, the cathode on the right supraorbital, 20min each session.

Intervention Type: DEVICE

Other Intervention Names

M1+DLPFC; sham tDCS; DLPFC

Eligibility Criteria

Inclusion Criteria

1. Aged 18-65 years;

2. Meet the diagnostic criteria for a depressive episode according to ICD-11, with current mild-to-moderate depressive symptoms (HAMD-24 score ≥8 and ≤34);

3. Report persistent pain lasting ≥3 months and score ≥4 on item 5 of the Brief Pain Inventory (BPI);

4. 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;

5. Right-handed, with normal hearing, vision, or corrected vision;

6. Able to voluntarily provide written informed consent to participate in the study and willing and capable of complying with all study procedures.

Exclusion Criteria

1. 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.

2. Active suicidal ideation, defined as a score of 4 on item 3 of the HAMD-24.

3. Severe or treatment-resistant depression (HAMD-24 score ≥35, with current depressive episode lasting at least 2 years or failure to respond to two or more antidepressant treatments during the current episode).

4. Substance use disorder within the past 3 months.

5. Experience of malignant pain due to cancer pain syndrome, visceral pain (e.g., gastric pain), or referred pain (e.g., back pain from pancreatitis).

6. Neurological disorders associated with structural brain abnormalities (e.g., traumatic brain injury, recent stroke, brain tumor).

7. Having undergone neuromodulation treatments within the past 3 months, including electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial electrical stimulation (tES).

8. 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).

9. Current or within the past 1 month use of medications affecting central nervous system excitability or pain, such as anticonvulsants, lithium, opioids, nonsteroidal anti-inflammatory drugs, and antipsychotics. Occasional as-needed use of acetaminophen as rescue medication is permitted but must be documented in detail in the study diary.

10. Signs of dementia or other severe cognitive impairment (MoCA score <17).

11. Severe or unstable somatic diseases, including but not limited to: neurological disorders (e.g., epilepsy, stroke, migraine, history of cranial surgery); cardiovascular diseases (e.g., uncontrolled hypertension, heart failure, arrhythmia, myocardial infarction); respiratory disorders (e.g., severe sleep apnea syndrome); malignancy or immunocompromised status; uncontrolled diabetes (fasting blood glucose >12 mmol/L).

12. Pregnancy or lactation.

13. Concurrent participation in another clinical trial, participation in any clinical trial within the past 90 days, or planned participation in another trial during the study period.

14. Any contraindications to magnetic resonance imaging (e.g., metal implants, claustrophobia, respiratory or motor impairments).

15. Inability to cooperate with study assessments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jianhua Chen

Role: CONTACT

jianhua.chen@smhc.org.cn

(+86) 18017311011

Facility Contacts

jianhua Chen

Role: primary

jianhua.chen@smhc.org.cn

(+86) 18017311011

haoyun Tang

Role: backup

tanghy0809@163.com

(+86) 18117197217

enzhao Cong

Role: primary

congenzhao@163.com

congenzhao@163.com

Other Identifiers

2025-80

Identifier Type: -

Identifier Source: org_study_id