Transcranial Direct Current StimulationNCT05286645
Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder
A study testing High definition transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Functional Magnetic Resonance Imaging, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Depressive Disorder
- What is being tested?
- High definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, PHQ-15>5.
- the age ranged from 18 to 60 years old
- right-handed
- stable dose of medication for at least 4 weeks or no history of antidepressive drugs before intervention
Who cannot join
- accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
- accompanied by other neurological diseases, such as stroke, epilepsy and so on.
- accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
- patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.
- pregnancy and breastfeeding.
- previous physical treatment (electroconvulsive therapy or tDCS).
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.
Read the detailed description
Depressive disorder is a major public health and safety problem around the world. Patients with depression often performe symptoms such as anhedonia, lack of motivation, somatic symptoms, and even suicidal ideation and behavior. The purpose of this study was to study the relieving effect of high definition transcranial direct current stimulation (HD-tDCS) on the symptoms of depression.
60 patients with depressive disorder diagnosed by DSM-5 were recruited from the fourth people's Hospital of Hefei and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tDCS. After meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tDCS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the HD-tDCS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included MoCA, Stroop Test, VFT, DST, AVLT, HAMD, HAMA, PHQ15, BSS(Beck scale for suicide ideation),ISI,SDS, RRS, TEPS, AES, FPQ, PVAQ and AAS. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL.
Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.
- Conditions
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Depressive Disorder
- Being tested
- High definition transcranial direct current stimulation, sham high definition transcranial direct current stimulation
- Keywords
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imagin, Depressive Disorder
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition transcranial direct current stimulationDevice
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.
sham high definition transcranial direct current stimulationDevice
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| real stimulation | Active comparator | Participants will receive active tDCS once daily for two weeks. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. Receives: Device: High definition transcranial direct current stimulation |
| sham stimulation | Placebo comparator | Participants will receive sham tDCS once daily for two weeks. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Receives: Device: sham high definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of somatic symptoms in active group and sham group at post-treatment and follow-up visit.
the somatic symptoms were assessed by PHQ-15 scale.
Measured: Baseline, Week 2 and Week 8.
the percentage decrease in PHQ-15 scores in active group and sham group at post-treatment and follow-up visit.
The percentage of decrease in scores was measured using the following formula: (pretreatment scores - post-treatment scores)/pretreatment scores × 100 %).
Measured: Baseline, Week 2 and Week 8.
the number of somatic responders in active group and sham group at post-treatment and follow-up visit.
Responders were defined as patients who had a ≥ 50% decrease in the PHQ-15 score.
Measured: Baseline, Week 2 and Week 8.
Secondary outcomes (3)
the change of depressive symptoms in active group and sham group at post-treatment and follow-up visit.
the depressive symptoms were assessed by HAMD scale.
Measured: Baseline, Week 2 and Week 8.
the percentage decrease in HAMD scores in active group and sham group at post-treatment and follow-up visit.
The percentage of decrease in scores was measured using the following formula: (pretreatment scores - post-treatment scores)/pretreatment scores × 100 %).
Measured: Baseline, Week 2 and Week 8.
the number of depressive responders in active group and sham group at post-treatment and follow-up visit.
Responders were defined as patients who had a ≥ 50% decrease in the HAMD score.
Measured: Baseline, Week 2 and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jan 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Ting Zhang, Study chair, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286645
- Sponsor's protocol ID
- AHMU-tdcs-depression
- Status last verified
- Sep 2024
- First submitted
- 13 Jan 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder
- ClinicalTrials.gov ID
- NCT05286645
- Acronym / sponsor ID
- AHMU-tdcs-depression
- Conditions
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Depressive Disorder
- Keywords
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imagin, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 Mar 2022 (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.
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.
Detailed description
Depressive disorder is a major public health and safety problem around the world. Patients with depression often performe symptoms such as anhedonia, lack of motivation, somatic symptoms, and even suicidal ideation and behavior. The purpose of this study was to study the relieving effect of high definition transcranial direct current stimulation (HD-tDCS) on the symptoms of depression.
60 patients with depressive disorder diagnosed by DSM-5 were recruited from the fourth people's Hospital of Hefei and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tDCS. After meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tDCS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the HD-tDCS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included MoCA, Stroop Test, VFT, DST, AVLT, HAMD, HAMA, PHQ15, BSS(Beck scale for suicide ideation),ISI,SDS, RRS, TEPS, AES, FPQ, PVAQ and AAS. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL.
Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real stimulation | Active comparator | Device: High definition transcranial direct current stimulationParticipants will receive active tDCS once daily for two weeks. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. |
| sham stimulation | Placebo comparator | Device: sham high definition transcranial direct current stimulationParticipants will receive sham tDCS once daily for two weeks. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, PHQ-15>5.
- the age ranged from 18 to 60 years old
- right-handed
- stable dose of medication for at least 4 weeks or no history of antidepressive drugs before intervention
Key exclusion criteria (6 listed)
- accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
- accompanied by other neurological diseases, such as stroke, epilepsy and so on.
- accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
- patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.
- pregnancy and breastfeeding.
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 |
|---|---|---|
| High definition transcranial direct current stimulationtDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes. | Device | real stimulation |
| sham high definition transcranial direct current stimulationSham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. | Device | sham stimulation |
Primary outcome
the change of somatic symptoms in active group and sham group at post-treatment and follow-up visit.
Time frame: Baseline, Week 2 and Week 8.
the somatic symptoms were assessed by PHQ-15 scale.
the percentage decrease in PHQ-15 scores in active group and sham group at post-treatment and follow-up visit.
Time frame: Baseline, Week 2 and Week 8.
The percentage of decrease in scores was measured using the following formula: (pretreatment scores - post-treatment scores)/pretreatment scores × 100 %).
the number of somatic responders in active group and sham group at post-treatment and follow-up visit.
Time frame: Baseline, Week 2 and Week 8.
Responders were defined as patients who had a ≥ 50% decrease in the PHQ-15 score.
3 secondary outcomes
the change of depressive symptoms in active group and sham group at post-treatment and follow-up visit.
Time frame: Baseline, Week 2 and Week 8.
the percentage decrease in HAMD scores in active group and sham group at post-treatment and follow-up visit.
Time frame: Baseline, Week 2 and Week 8.
the number of depressive responders in active group and sham group at post-treatment and follow-up visit.
Time frame: Baseline, Week 2 and Week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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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. This study is not recruiting at the moment.
Ting Zhang study chair
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High definition transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Functional Magnetic Resonance Imaging, run by Anhui Medical University at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of somatic symptoms in active group and sham group at post-treatment and follow-up visit. (time frame: Baseline, Week 2 and Week 8.). The study lists 3 primary outcomes in all. 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 12 Jan 2026.