DepressionNCT07287878
Neural Mechanisms of Temporal Interference Stimulation on Improving Social Reward Function in Depression
A study testing Temporal Interference Simulation(TIS) and Temporal Interference Stimulation(TIS) in people with Depression, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Major depressive disorder (MDD) is a mood disorder characterized primarily by low mood, diminished interest, and reduced energy. Traditional views considered depression a non-degenerative condition; however, recent epidemiological studies have revealed its significant association with impaired social functioning. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Temporal Interference Simulation(TIS) and Temporal Interference Stimulation(TIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 10 Jul 2026
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 16-60 years old;
- Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
- Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
- With enough audio-visual ability and comprehensive ability to accomplish the visits;
- Be necessary and suitable to accept the treatment of antidepressants;
- Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
- With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.
Who cannot join
- Severe medical or neurological problems;
- Previous mania or hypomania episodes;
- Female patients who are pregnant, planning to be pregnant or breastfeeding;
- Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
- Had ECT, MECT or rTMS in the past 6 months;
- Experienced severe personality disorder, mental retardation, anorexia/ bulimia nervosa.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, China
About this study
Major depressive disorder (MDD) is a mood disorder characterized primarily by low mood, diminished interest, and reduced energy. Traditional views considered depression a non-degenerative condition; however, recent epidemiological studies have revealed its significant association with impaired social functioning. Data indicate that 59.3% of patients with depression experience social dysfunction of varying severity [1], particularly manifesting as difficulties in social interaction and relationship maintenance [2]. Therefore, investigating the mechanisms underlying social dysfunction is of great importance for promoting functional recovery in MDD, and dysfunction within the social reward system may represent a core factor, though the specific neural mechanisms remain unclear.
The ultimate goal of understanding the neural mechanisms underlying social reward impairment in depressed patients is to improve therapeutic outcomes. Temporal Interference (TI) stimulation, as a non-invasive deep brain stimulation technique, utilizes high-frequency current differentials to generate low-frequency amplitude-modulated electric fields, enabling precise targeting of deep brain regions. This study employs multimodal assessment methods-such as functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific cognitive-behavioral tasks-combined with TI stimulation to observe immediate changes in functional connectivity, neural activity, and related cognitive functions (e.g., decision-making, memory) across participant groups. The research aims to elucidate the roles of the parahippocampal gyrus, orbitofrontal cortex, and striatum in social reward impairment in depression, and to explore circuit-based intervention targets, thereby providing novel strategies for the recovery of social functioning in MDD.
- Conditions
- Depression
- Being tested
- Temporal Interference Simulation(TIS), Temporal Interference Stimulation(TIS)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference Simulation(TIS)Device
the total stimulation duration was 20 minutes, including a 40-second current ramp-up at the beginning and a 40-second ramp-down at the end.
Temporal Interference Stimulation(TIS)Device
Sham stimulation has only 40 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation to simulate the sensation of actual stimulation.
| Study group | Role | What they receive |
|---|---|---|
| orbitofrontal cortex | Experimental | Not described Receives: Device: Temporal Interference Simulation(TIS) |
| parahippocampal gyrus | Experimental | Not described Receives: Device: Temporal Interference Simulation(TIS) |
| striatum | Experimental | Not described Receives: Device: Temporal Interference Simulation(TIS) |
| sham | Sham comparator | Not described Receives: Device: Temporal Interference Stimulation(TIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HAMD) Score
The HAMD is a clinical depression assessment and consists of 17 items with a total score range from 0 to 54.A higher score indicates a worse outcome.
Measured: baseline and immediately after the intervention
Change in The Positive and Negative Affect Schedule (PANAS) Score
The Positive and Negative Affect Schedule (PANAS) is an assessment of participants' immediate affective states and consists of 20 items divided into two subscales (10 items for Positive Affect and 10 items for Negative Affect), with each item rated on a 5-point scale; higher scores on the Positive Affect subscale indicate more positive emotional states, while higher scores on the Negative Affect subscale indicate more negative emotional states.
Measured: Baseline and immediately after the intervention
Secondary outcomes (1)
MRI measures
The functional connectivity between stimulated target and the whole brain areas
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Nov 2025
- Primary completion10 May 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287878
- Sponsor's protocol ID
- 22YF1439100
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Temporal Interference Stimulation on Improving Social Reward Function in Depression
- ClinicalTrials.gov ID
- NCT07287878
- Acronym / sponsor ID
- 22YF1439100
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
Major depressive disorder (MDD) is a mood disorder characterized primarily by low mood, diminished interest, and reduced energy. Traditional views considered depression a non-degenerative condition; however, recent epidemiological studies have revealed its significant association with impaired social functioning. Data indicate that 59.3% of patients with depression experience social dysfunction of varying severity [1], particularly manifesting as difficulties in social interaction and relationship maintenance [2]. Therefore, investigating the mechanisms underlying social dysfunction is of great importance for promoting functional recovery in MDD, and dysfunction within the social reward system may represent a core factor, though the specific neural mechanisms remain unclear.
The ultimate goal of understanding the neural mechanisms underlying social reward impairment in depressed patients is to improve therapeutic outcomes. Temporal Interference (TI) stimulation, as a non-invasive deep brain stimulation technique, utilizes high-frequency current differentials to generate low-frequency amplitude-modulated electric fields, enabling precise targeting of deep brain regions. This study employs multimodal assessment methods-such as functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific cognitive-behavioral tasks-combined with TI stimulation to observe immediate changes in functional connectivity, neural activity, and related cognitive functions (e.g., decision-making, memory) across participant groups. The research aims to elucidate the roles of the parahippocampal gyrus, orbitofrontal cortex, and striatum in social reward impairment in depression, and to explore circuit-based intervention targets, thereby providing novel strategies for the recovery of social functioning in MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| orbitofrontal cortex | Experimental | Device: Temporal Interference Simulation(TIS) |
| parahippocampal gyrus | Experimental | Device: Temporal Interference Simulation(TIS) |
| striatum | Experimental | Device: Temporal Interference Simulation(TIS) |
| sham | Sham comparator | Device: Temporal Interference Stimulation(TIS) |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 16-60 years old;
- Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
- Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
- With enough audio-visual ability and comprehensive ability to accomplish the visits;
- Be necessary and suitable to accept the treatment of antidepressants;
Key exclusion criteria (6 listed)
- Severe medical or neurological problems;
- Previous mania or hypomania episodes;
- Female patients who are pregnant, planning to be pregnant or breastfeeding;
- Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
- Had ECT, MECT or rTMS in the past 6 months;
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 |
|---|---|---|
| Temporal Interference Simulation(TIS)the total stimulation duration was 20 minutes, including a 40-second current ramp-up at the beginning and a 40-second ramp-down at the end. | Device | orbitofrontal cortex, parahippocampal gyrus, striatum |
| Temporal Interference Stimulation(TIS)Sham stimulation has only 40 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation to simulate the sensation of actual stimulation. | Device | sham |
Primary outcome
Change in Hamilton Depression Rating Scale (HAMD) Score
Time frame: baseline and immediately after the intervention
The HAMD is a clinical depression assessment and consists of 17 items with a total score range from 0 to 54.A higher score indicates a worse outcome.
Change in The Positive and Negative Affect Schedule (PANAS) Score
Time frame: Baseline and immediately after the intervention
The Positive and Negative Affect Schedule (PANAS) is an assessment of participants' immediate affective states and consists of 20 items divided into two subscales (10 items for Positive Affect and 10 items for Negative Affect), with each item rated on a 5-point scale; higher scores on the Positive Affect subscale indicate more positive emotional states, while higher scores on the Negative Affect subscale indicate more negative emotional states.
1 secondary outcome
MRI measures
Time frame: Baseline and immediately after the intervention
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 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Simulation(TIS) and Temporal Interference Stimulation(TIS) in people with Depression, run by Shanghai Mental Health Center 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 7 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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?
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 daihui Peng, MD. PhD. (18017311136, pdhsh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HAMD) Score (time frame: baseline and immediately after the intervention). The study lists 2 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 24 Dec 2025.