Depression DisorderNCT07334561
Transcranial Electrical Stimulation for Comorbid Depression and Chronic Pain
A study testing tDCS and alpha-tACS in people with Depression Disorder and Chronic Pain, run by Shanghai Mental Health Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression Disorder, Chronic Pain
- What is being tested?
- tDCS and alpha-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for a depressive episode (DSM-5);
- HAMD-17 score of ≥8 and ≤23 (mild-to-moderate depressive symptoms) based on the current assessment;
- 4 or higher on Item 5 of the Brief Pain Inventory (BPI), and persistent pain lasting more than three months;
- Ages 18-80;
- Right-handed, with normal hearing, vision, or corrected vision;
- Have a high school education or higher and be able to understand and complete research-related assessments;
- Maintain a consistent regimen of analgesic and antidepressant medications and psychotherapy (including dosage and type of medication or treatment method) for four weeks prior to enrollment;
- The subject (or his or her legal representative, if applicable) signed an informed consent form stating that he or she understood the purpose and procedure of the trial and was willing to participate in it.
Who cannot join
- Diagnosed according to the DSM-5 as meeting any of the following criteria: ① Major depressive disorder or treatment-resistant depression (HAMD-17 score ≥ 24, and the current episode has lasted ≥ 2 years, or the current episode has been unresponsive to treatment with ≥ 2 antidepressants); ② Schizophrenia spectrum disorder; ③ Bipolar I disorder; ④ Anxiety disorders (including generalized anxiety disorder, panic disorder, social anxiety disorder, etc.); ⑤ Depressive disorder caused by a medical condition.
- Experiencing malignant pain caused by cancer pain syndrome, visceral pain (such as stomach pain), referred pain (such as back pain caused by pancreatitis), and so on;
- Patients with severe or unstable physical illnesses, including but not limited to: neurological disorders (such as epilepsy, stroke, migraine, history of cranial surgery, etc.); neurological disorders accompanied by structural brain abnormalities (e.g., traumatic brain injury, recent stroke, brain tumor); cardiovascular diseases (e.g., uncontrolled hypertension, heart failure, arrhythmias, myocardial infarction, etc.); respiratory diseases (e.g., severe sleep apnea syndrome); malignant tumors or immunodeficiency; uncontrolled diabetes (fasting blood glucose > 12 mmol/L);
- Excessive alcohol consumption within 30 days prior to the start of the trial, or a history of alcohol or drug dependence within the past 6 months;
- Women who are pregnant, breastfeeding, or planning to become pregnant within 3 months of the start of the trial;
- Currently taking medications that affect cortical excitability (e.g., benzodiazepines, antiepileptic drugs);
Show all 16Show fewer
- Have undergone neurostimulation therapy within the past 3 months, including electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial electrical stimulation (tES);
- Suffers from claustrophobia and is unable to undergo an fMRI scan (applies to subjects who require a functional MRI scan);
- Contraindications to transcranial electrical stimulation (such as intracranial metal implants, pacemakers, cochlear implants, skin abrasions at the stimulation site, or a personal or family history of epilepsy, etc.);
- Currently participating in another clinical trial, has participated in a clinical trial within the past 90 days, or plans to participate in another clinical trial during the study;
- Participants with obvious suicidal tendencies, impulsive behavior, or an inability to cooperate with study evaluators;
- Accompanied by psychotic symptoms;
- Researchers believe there are other circumstances that make a participant unsuitable for the trial;
- Patients with severe cognitive impairment (MMSE ≤ 17) were excluded;
- Participants who are unable to cooperate with the study;
- Those who voluntarily withdrew midway.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
jianhua Chen, (+86) 18017311011, jianhua.chen@smhc.org.cn
haoyun Tang, (+86) 18117197217, tanghy0809@163.com
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
enzhao Cong, congenzhao@163.com, congenzhao@163.com
About this study
Official title: Transcranial Electrical Stimulation for Comorbid Depression and Pain: From Technological Development to Clinical Translation in a Multicenter Trial
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:
- Are there any differences in the overall efficacy among the three intervention groups (tACS, tDCS, and sham)?
- 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?
- Is active tACS superior to active tDCS in reducing pain symptoms?
- Does active tACS, compared to tDCS, demonstrate a more persistent improvement in pain symptoms, as measured at the 6-week follow-up?
- As an exploratory objective, what neural oscillation entrainment mechanisms underlie the potential analgesic effects of tACS?
Read more
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:
- Receive 40 minutes of stimulation (tACS, tDCS, or sham) once daily, 5 days per week, for 2 weeks (10 sessions total).
- Complete clinical assessments and cognitive tests at baseline, mid-intervention (week 1), post-intervention (week 2), and at a 6-week follow-up.
- 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:
- 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.
- 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.
- Conditions
- Depression Disorder, Chronic Pain
- Being tested
- tDCS, alpha-tACS, Sham
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Participants receive active tDCS. The anodal electrode (5 × 5 cm) is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode (5 × 7 cm) is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 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).
alpha-tACSDevice
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. 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).
ShamDevice
Sham group using the same electrode montage at F3/F4. 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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Participants receive active tDCS. The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 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). Receives: Device: tDCS |
| alpha-tACS | Experimental | Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. 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). Receives: Device: alpha-tACS |
| Sham | Sham comparator | Sham group using the same electrode montage at F3/F4. 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. Receives: Device: Sham |
| Exploratory Open-Label tACS Group | Experimental | Participants in this exploratory arm receive the same active tACS intervention as Arm alpha-tACS, with identical stimulation parameters (e.g., 1 mA, 40 minutes, 10 Hz, targeting the bilateral dorsolateral prefrontal cortex (DLPFC)). This arm is open-label (unblinded): participants and study personnel are aware of the treatment assignment. It serves as a supplementary exploratory cohort to explore preliminary neural oscillation entrainment effects of tACS. Unlike Arms 1-3, this arm is neither randomized nor blinded. Data from this arm will be analyzed separately and are not included in the primary confirmatory hypothesis testing of the randomized controlled trial. The overall study remains double-blind for the three-arm RCT component, with this exploratory arm conducted as an ancillary cohort. Receives: Device: alpha-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving MCID on BPI Pain Intensity Subscale
Description:
The BPI is a validated self-administered questionnaire that assesses the severity of pain and its impact on daily functioning. The pain intensity subscale consists of four items rating pain at its "worst," "least," "average," and "current" (right now). Each item is rated on a 0 to 10 numeric rating scale. Higher scores mean a worse outcome.
The Minimal Clinically Important Difference (MCID) is defined as a reduction of ≥ 1 point from baseline in the BPI pain intensity score. The outcome is the proportion of participants in each group who achieve this MCID threshold at each follow-up time point.
Measured: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Secondary outcomes (6)
Percentage Reduction from Baseline in HAMD-17 Total Score
The HAMD-17 is a 17-item clinician-rated scale assessing depression severity. Items are rated on 3- or 5-point scales, with total scores ranging from 0 to 52. Higher scores mean a worse outcome (greater depression severity).
The outcome is the percentage reduction in HAMD-17 total score from baseline at each follow-up time point, calculated using the formula:
[(Baseline score - Follow-up score) / Baseline score] × 100%
A positive percentage indicates improvement (reduction in depressive symptoms).
Measured: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in HAMD-17 Total Score
The Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-rated scale assessing depression severity. Items are rated on 3- or 5-point scales, with total scores ranging from 0 to 52. Higher scores indicate greater depression severity (worse outcome). The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)]. A positive change value indicates improvement (reduction in depressive symptoms). No pre-defined clinically meaningful threshold is applied to this continuous outcome; it is reported as the mean absolute change per group.
Measured: At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Pain Catastrophizing Scale (PCS) Total Score
The Pain Catastrophizing Scale (PCS) is a 13-item self-reported questionnaire. Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (all the time), with total scores ranging from 0 to 52. Higher scores indicate higher levels of pain catastrophizing (worse outcome). The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)]. A positive change value indicates improvement (reduction in pain catastrophizing).
Measured: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Generalized Anxiety Disorder Scale-7 (GAD-7) Total Score
The GAD-7 is a 7-item self-report scale (0-21, higher scores = worse outcome) assessing anxiety symptoms over the past two weeks. The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)].
Measured: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Clinical Global Impression (CGI) Total Score
The Clinical Global Impression (CGI) scale consists of two clinician-rated subscales assessing overall treatment response:
CGI-Severity (CGI-S): Rates the severity of the patient's illness on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores mean a worse outcome.
CGI-Improvement (CGI-I): Rates the patient's improvement compared to baseline on a 7-point scale from 1 (very much improved) to 7 (very much worse). This subscale is only assessed at post-baseline time points. Lower scores mean a better outcome (greater improvement).
The outcome is the change from baseline in CGI-S score at each follow-up time point, and the CGI-I score at each post-baseline time point.
Measured: At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Resting-State Functional Connectivity of the DLPFC at 2 Weeks
Resting-state functional connectivity (rs-FC) of the dorsolateral prefrontal cortex (DLPFC) is assessed using resting-state functional magnetic resonance imaging (rs-fMRI). The primary measurement is the change in seed-based functional connectivity strength between the DLPFC and its target network regions (e.g., parietal cortex, default mode network nodes), quantified as Fisher-transformed correlation coefficients (z-values) from a priori defined regions of interest. Higher z-values indicate stronger positive functional connectivity; lower or negative values indicate weaker or anticorrelated connectivity. Structural MRI (sMRI) is acquired for co-registration and normalization purposes.
Measured: Baseline and immediately after the 2-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334561
- Sponsor's protocol ID
- 2025-80
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation for Comorbid Depression and Pain: From Technological Development to Clinical Translation in a Multicenter Trial
- ClinicalTrials.gov ID
- NCT07334561
- Acronym / sponsor ID
- 2025-80
- Conditions
- Depression Disorder, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are there any differences in the overall efficacy among the three intervention groups (tACS, tDCS, and sham)?
- 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?
- Is active tACS superior to active tDCS in reducing pain symptoms?
- Does active tACS, compared to tDCS, demonstrate a more persistent improvement in pain symptoms, as measured at the 6-week follow-up?
- 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:
- Receive 40 minutes of stimulation (tACS, tDCS, or sham) once daily, 5 days per week, for 2 weeks (10 sessions total).
- Complete clinical assessments and cognitive tests at baseline, mid-intervention (week 1), post-intervention (week 2), and at a 6-week follow-up.
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCSParticipants receive active tDCS. The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 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). |
| alpha-tACS | Experimental | Device: alpha-tACSParticipants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. 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 | Sham comparator | Device: ShamSham group using the same electrode montage at F3/F4. 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. |
| Exploratory Open-Label tACS Group | Experimental | Device: alpha-tACSParticipants in this exploratory arm receive the same active tACS intervention as Arm alpha-tACS, with identical stimulation parameters (e.g., 1 mA, 40 minutes, 10 Hz, targeting the bilateral dorsolateral prefrontal cortex (DLPFC)). This arm is open-label (unblinded): participants and study personnel are aware of the treatment assignment. It serves as a supplementary exploratory cohort to explore preliminary neural oscillation entrainment effects of tACS. Unlike Arms 1-3, this arm is neither randomized nor blinded. Data from this arm will be analyzed separately and are not included in the primary confirmatory hypothesis testing of the randomized controlled trial. The overall study remains double-blind for the three-arm RCT component, with this exploratory arm conducted as an ancillary cohort. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meets the diagnostic criteria for a depressive episode (DSM-5);
- HAMD-17 score of ≥8 and ≤23 (mild-to-moderate depressive symptoms) based on the current assessment;
- 4 or higher on Item 5 of the Brief Pain Inventory (BPI), and persistent pain lasting more than three months;
- Ages 18-80;
- Right-handed, with normal hearing, vision, or corrected vision;
Key exclusion criteria (16 listed)
- Diagnosed according to the DSM-5 as meeting any of the following criteria: ① Major depressive disorder or treatment-resistant depression (HAMD-17 score ≥ 24, and the current episode has lasted ≥ 2 years, or the current episode has been unresponsive to treatment with ≥ 2 antidepressants); ② Schizophrenia spectrum disorder; ③ Bipolar I disorder; ④ Anxiety disorders (including generalized anxiety disorder, panic disorder, social anxiety disorder, etc.); ⑤ Depressive disorder caused by a medical condition.
- Experiencing malignant pain caused by cancer pain syndrome, visceral pain (such as stomach pain), referred pain (such as back pain caused by pancreatitis), and so on;
- Patients with severe or unstable physical illnesses, including but not limited to: neurological disorders (such as epilepsy, stroke, migraine, history of cranial surgery, etc.); neurological disorders accompanied by structural brain abnormalities (e.g., traumatic brain injury, recent stroke, brain tumor); cardiovascular diseases (e.g., uncontrolled hypertension, heart failure, arrhythmias, myocardial infarction, etc.); respiratory diseases (e.g., severe sleep apnea syndrome); malignant tumors or immunodeficiency; uncontrolled diabetes (fasting blood glucose > 12 mmol/L);
- Excessive alcohol consumption within 30 days prior to the start of the trial, or a history of alcohol or drug dependence within the past 6 months;
- Women who are pregnant, breastfeeding, or planning to become pregnant within 3 months of the start of the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSParticipants receive active tDCS. The anodal electrode (5 × 5 cm) is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode (5 × 7 cm) is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 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). | Device | tDCS |
| alpha-tACSParticipants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. 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). | Device | Exploratory Open-Label tACS Group, alpha-tACS |
| ShamSham group using the same electrode montage at F3/F4. 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. | Device | Sham |
Primary outcome
Proportion of Participants Achieving MCID on BPI Pain Intensity Subscale
Time frame: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Description: The BPI is a validated self-administered questionnaire that assesses the severity of pain and its impact on daily functioning. The pain intensity subscale consists of four items rating pain at its "worst," "least," "average," and "current" (right now). Each item is rated on a 0 to 10 numeric rating scale. Higher scores mean a worse outcome. The Minimal Clinically Important Difference (MCID) is defined as a reduction of ≥ 1 point from baseline in the BPI pain intensity score. The outcome is the proportion of participants in each group who achieve this MCID threshold at each follow-up time point.
6 secondary outcomes
Percentage Reduction from Baseline in HAMD-17 Total Score
Time frame: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in HAMD-17 Total Score
Time frame: At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Pain Catastrophizing Scale (PCS) Total Score
Time frame: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Generalized Anxiety Disorder Scale-7 (GAD-7) Total Score
Time frame: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Clinical Global Impression (CGI) Total Score
Time frame: At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Resting-State Functional Connectivity of the DLPFC at 2 Weeks
Time frame: Baseline and immediately after the 2-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Depression Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and alpha-tACS in people with Depression Disorder and Chronic Pain, run by Shanghai Mental Health Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Chen ((+86) 18017311011, jianhua.chen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving MCID on BPI Pain Intensity Subscale (time frame: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.