Major Depressive Disorder (MDD)NCT07888387
Temporal Interference Stimulation in Major Depressive Disorder: A Pilot Feasibility Study
A study testing Temporal Interference Stimulation in people with Major Depressive Disorder (MDD), run by Ruijin Hospital at 1 site in China.
Trial summary
This pilot feasibility study used a randomized, double-blind, within-subject crossover design to explore temporal interference (TI) stimulation in adults with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 27 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years, male or female.
- Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), made by an experienced clinician.
- Hamilton Depression Rating Scale-17 (HAMD-17) score of 17 or higher.
- No change in antidepressant medication regimen from 30 days before study participation and throughout the study.
Who cannot join
- History of other psychiatric disorders, such as schizophrenia or dementia, that in the investigator's judgment could affect the study results.
- History of neurological disorders, such as seizures.
- Presence of implants, including metallic foreign bodies in the skull or metallic cardiac implants.
- Receipt of neurostimulation therapy within the previous 3 months.
- High suicide risk as assessed by an experienced clinician.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulating Emotional and Cognitive Circuits in Major Depressive Disorder Via Temporal Interference Stimulation
This pilot feasibility study used a randomized, double-blind, within-subject crossover design to explore temporal interference (TI) stimulation in adults with major depressive disorder. Fifteen participants received five weekly 20-minute stimulation sessions in randomized order, including TI stimulation targeting the left dorsolateral prefrontal cortex, left subgenual anterior cingulate cortex, right amygdala, and right ventral striatum, as well as a sham stimulation condition. The primary aim was to establish the feasibility of target-specific TI stimulation and to characterize its effects on functional connectivity and cognitive-emotional processing, assessed by resting-state fMRI and an emotional Stroop task before and after each session. Depressive and anxiety symptoms (HAMD and HAMA) were collected longitudinally across the five-week protocol as a secondary, exploratory measure.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Temporal Interference Stimulation
- Keywords
- Temporal Interference, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationDevice
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal Interference StimulationDevice
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal Interference StimulationDevice
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal Interference StimulationDevice
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal Interference StimulationDevice
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
| Study group | Role | What they receive |
|---|---|---|
| left DLPFC TI stimulation | Experimental | Temporal interference stimulation targeting the left dorsolateral prefrontal cortex (DLPFC), using a 10-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. Receives: Device: Temporal Interference Stimulation |
| Left sgACC-TI Stimulation | Experimental | Temporal interference stimulation targeting the left subgenual anterior cingulate cortex (sgACC), using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. Receives: Device: Temporal Interference Stimulation |
| Right Amygdala-TI Stimulation | Experimental | Temporal interference stimulation targeting the right amygdala, using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. Receives: Device: Temporal Interference Stimulation |
| Right Ventral Striatum-TI Stimulation | Experimental | Temporal interference stimulation targeting the right ventral striatum, using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. Receives: Device: Temporal Interference Stimulation |
| Sham TI Stimulation | Experimental | For sham stimulation, two currents at the same 2-kHz frequency were applied using an electrode configuration randomly selected from one of the four active target montages, producing a 0-Hz difference frequency. Current was delivered so that participants could not distinguish sham from active stimulation. Stimulation lasted 20 minutes. Receives: Device: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed All Five Stimulation Sessions
Feasibility, defined as the number of enrolled participants who completed all five weekly 20-minute stimulation sessions. Reported descriptively; no formal hypothesis test.
Measured: Up to 5 weeks
Number of Participants With Adverse Events
Tolerability, defined as the number of participants experiencing at least one adverse event during or after any of the five stimulation sessions, summarized by severity (mild, moderate, severe). Reported descriptively; no formal hypothesis test.
Measured: Up to 5 weeks
Participant-Reported Discomfort During Stimulation
Discomfort during each 20-minute session, record the number of participants reporting any discomfort. Reported descriptively; no formal hypothesis test.
Measured: Immediately after each of the five weekly sessions (Weeks 1-5)
Change in resting-state functional connectivity
Seed-based resting-state functional connectivity computed from fMRI acquired immediately before and after each session. For each target, FC is the Fisher z-transformed temporal correlation between the seed time series and other voxels. Outcome is the pre-to-post change (post minus pre) under active stimulation versus sham, at group level.
Measured: Immediately before and after each stimulation session
Secondary outcomes (2)
Change in depressive symptoms (HAMD)
Depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17). Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms (worse outcome). Outcome is the change in total score from baseline, analyzed as a secondary, exploratory measure. Study not powered for target-specific or antidepressant effects.
Measured: Baseline (before the first session), Weeks 2, 3, 4,5,7
Change in anxiety symptoms (HAMA)
Anxiety symptom severity measured by the 14-item Hamilton Anxiety Rating Scale (HAMA). Total score ranges from 0 to 56; higher scores indicate more severe anxiety symptoms (worse outcome). Outcome is the change in total score from baseline, analyzed as a secondary, exploratory measure.
Measured: Baseline, Weeks 2, 3, 4, 5, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start25 Aug 2023
- Primary completion20 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888387
- Sponsor's protocol ID
- 2026180
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Emotional and Cognitive Circuits in Major Depressive Disorder Via Temporal Interference Stimulation
- ClinicalTrials.gov ID
- NCT07888387
- Acronym / sponsor ID
- 2026180
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Temporal Interference, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 22 Oct 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.
This pilot feasibility study used a randomized, double-blind, within-subject crossover design to explore temporal interference (TI) stimulation in adults with major depressive disorder. Fifteen participants received five weekly 20-minute stimulation sessions in randomized order, including TI stimulation targeting the left dorsolateral prefrontal cortex, left subgenual anterior cingulate cortex, right amygdala, and right ventral striatum, as well as a sham stimulation condition. The primary aim was to establish the feasibility of target-specific TI stimulation and to characterize its effects on functional connectivity and cognitive-emotional processing, assessed by resting-state fMRI and an emotional Stroop task before and after each session. Depressive and anxiety symptoms (HAMD and HAMA) were collected longitudinally across the five-week protocol as a secondary, exploratory measure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| left DLPFC TI stimulation | Experimental | Device: Temporal Interference StimulationTemporal interference stimulation targeting the left dorsolateral prefrontal cortex (DLPFC), using a 10-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. |
| Left sgACC-TI Stimulation | Experimental | Device: Temporal Interference StimulationTemporal interference stimulation targeting the left subgenual anterior cingulate cortex (sgACC), using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. |
| Right Amygdala-TI Stimulation | Experimental | Device: Temporal Interference StimulationTemporal interference stimulation targeting the right amygdala, using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. |
| Right Ventral Striatum-TI Stimulation | Experimental | Device: Temporal Interference StimulationTemporal interference stimulation targeting the right ventral striatum, using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods. |
| Sham TI Stimulation | Experimental | Device: Temporal Interference StimulationFor sham stimulation, two currents at the same 2-kHz frequency were applied using an electrode configuration randomly selected from one of the four active target montages, producing a 0-Hz difference frequency. Current was delivered so that participants could not distinguish sham from active stimulation. Stimulation lasted 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years, male or female.
- Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), made by an experienced clinician.
- Hamilton Depression Rating Scale-17 (HAMD-17) score of 17 or higher.
- No change in antidepressant medication regimen from 30 days before study participation and throughout the study.
Key exclusion criteria (6 listed)
- History of other psychiatric disorders, such as schizophrenia or dementia, that in the investigator's judgment could affect the study results.
- History of neurological disorders, such as seizures.
- Presence of implants, including metallic foreign bodies in the skull or metallic cardiac implants.
- Receipt of neurostimulation therapy within the previous 3 months.
- High suicide risk as assessed by an experienced clinician.
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 StimulationTemporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity. | Device | left DLPFC TI stimulation |
| Temporal Interference StimulationTemporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity. | Device | Left sgACC-TI Stimulation |
| Temporal Interference StimulationTemporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity. | Device | Right Amygdala-TI Stimulation |
| Temporal Interference StimulationTemporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity. | Device | Right Ventral Striatum-TI Stimulation |
| Temporal Interference StimulationTemporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity. | Device | Sham TI Stimulation |
Primary outcome
Number of Participants Who Completed All Five Stimulation Sessions
Time frame: Up to 5 weeks
Feasibility, defined as the number of enrolled participants who completed all five weekly 20-minute stimulation sessions. Reported descriptively; no formal hypothesis test.
Number of Participants With Adverse Events
Time frame: Up to 5 weeks
Tolerability, defined as the number of participants experiencing at least one adverse event during or after any of the five stimulation sessions, summarized by severity (mild, moderate, severe). Reported descriptively; no formal hypothesis test.
Participant-Reported Discomfort During Stimulation
Time frame: Immediately after each of the five weekly sessions (Weeks 1-5)
Discomfort during each 20-minute session, record the number of participants reporting any discomfort. Reported descriptively; no formal hypothesis test.
Change in resting-state functional connectivity
Time frame: Immediately before and after each stimulation session
Seed-based resting-state functional connectivity computed from fMRI acquired immediately before and after each session. For each target, FC is the Fisher z-transformed temporal correlation between the seed time series and other voxels. Outcome is the pre-to-post change (post minus pre) under active stimulation versus sham, at group level.
2 secondary outcomes
Change in depressive symptoms (HAMD)
Time frame: Baseline (before the first session), Weeks 2, 3, 4,5,7
Change in anxiety symptoms (HAMA)
Time frame: Baseline, Weeks 2, 3, 4, 5, and 7
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 22 Oct 2026.
Related trials for Major Depressive Disorder (MDD)
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stimulation in people with Major Depressive Disorder (MDD), run by Ruijin Hospital 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 22 Oct 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. 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?
Number of Participants Who Completed All Five Stimulation Sessions (time frame: Up to 5 weeks). The study lists 4 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 22 Oct 2026.