Major Depressive Disorder (MDD)NCT07612501
Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression
A study testing Active Transcranial Temporal Interference Stimulation Targeting Left ALIC and Active Transcranial Temporal Interference Stimulation Targeting Left sgACC in people with Major Depressive Disorder (MDD), run by Yonggui Yuan at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function. 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?
- Active Transcranial Temporal Interference Stimulation Targeting Left ALIC and Active Transcranial Temporal Interference Stimulation Targeting Left sgACC
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 May 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists
- 24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline
- Aged 18 to 65 years
- Right-handed
- Able to understand the study procedures and willing to provide written informed consent
Who cannot join
- History of epilepsy, brain tumor, or brain trauma
- Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months
- Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging
- Acute or severe suicidal ideation
- Any other condition judged by the investigators to make participation unsuitable for this study
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
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Yue Zhou, MD Candidate, +86 15651003002, 2725106172@qq.com
Yubo Zhang, MD Candidate, +86 1865161780, 1301053461@qq.com
About this study
The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function.
The main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS.
Read more
Researchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment.
Participants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.
Read the detailed description
Major depressive disorder (MDD) is a common and disabling mental disorder. Although medication, psychotherapy, and established brain stimulation methods can help many people with MDD, some participants still have insufficient improvement. Transcranial temporal interference stimulation (tTIS) is a non-invasive brain stimulation technique that may allow modulation of deeper brain regions or pathways. This study is designed to evaluate whether tTIS can improve depressive symptoms in adults with MDD, assess its safety, and explore potential neuroimaging mechanisms.
This is a single-center, randomized, double-blind, sham-controlled clinical trial conducted at Zhongda Hospital, Southeast University. Eligible participants with MDD will be randomly assigned in a 1:1:1 ratio to one of three groups: active tTIS targeting the left anterior limb of the internal capsule (ALIC), active tTIS targeting the left subgenual anterior cingulate cortex (sgACC), or sham tTIS. The sham stimulation will be designed to provide sensory feedback similar to active stimulation while maintaining blinding.
Participants with MDD will receive 10 treatment sessions over 5 consecutive days, with two 20-minute sessions each day. Clinical symptoms and safety will be assessed at baseline, after treatment, and during follow-up. The main clinical outcome is the change in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline to after treatment. Secondary outcomes include follow-up changes in depressive symptoms, response and remission rates, anxiety symptoms, anhedonia, psychosomatic symptoms, side effects, and adverse events.
Multimodal 5.0T brain magnetic resonance imaging (MRI) will be collected from participants with MDD before and after treatment. MRI measures will include structural imaging, resting-state functional imaging, and diffusion imaging. These data will be used to explore changes in brain structure, functional connectivity, and diffusion-related measures after tTIS, and to identify potential imaging biomarkers related to treatment response.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Active Transcranial Temporal Interference Stimulation Targeting Left ALIC, Active Transcranial Temporal Interference Stimulation Targeting Left sgACC, Sham Transcranial Temporal Interference Stimulation
- Keywords
- Major Depressive Disorder, Transcranial Temporal Interference Stimulation, Noninvasive Brain Stimulation, Anterior Limb of the Internal Capsule, Subgenual Anterior Cingulate Cortex, Magnetic Resonance Imaging
- 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.
Active Transcranial Temporal Interference Stimulation Targeting Left ALICDevice
Also called Active tTIS Targeting Left ALIC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Active Transcranial Temporal Interference Stimulation Targeting Left sgACCDevice
Also called Active tTIS Targeting Left sgACC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Sham Transcranial Temporal Interference StimulationDevice
Also called Sham tTIS
Participants in this arm will receive sham transcranial temporal interference stimulation (tTIS) using the same type of device as active stimulation. Sham stimulation will provide sensory feedback similar to active stimulation to help maintain masking, but it will not deliver the same active treatment dose. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Active tTIS Targeting Left ALIC | Active comparator | Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions. Receives: Device: Active Transcranial Temporal Interference Stimulation Targeting Left ALIC |
| Active tTIS Targeting Left sgACC | Active comparator | Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions. Receives: Device: Active Transcranial Temporal Interference Stimulation Targeting Left sgACC |
| Sham tTIS | Sham comparator | Participants in this arm will receive sham transcranial temporal interference stimulation (tTIS). Sham stimulation will be delivered using the same type of device and will provide sensory feedback similar to active stimulation, but it will not provide the same active treatment dose. Treatment sessions will follow the same schedule as the active stimulation arms. Receives: Device: Sham Transcranial Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess the severity of depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. The primary outcome is the change in HAMD-24 total score from baseline to Week 1.
Measured: Baseline and Week 1
Secondary outcomes (18)
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 2
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. This outcome measures the change in HAMD-24 total score from baseline to Week 2.
Measured: Baseline and Week 2
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 6
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. This outcome measures the change in HAMD-24 total score from baseline to Week 6.
Measured: Baseline and Week 6
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 1.
Measured: Week 1
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 2.
Measured: Week 2
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 6.
Measured: Week 6
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline. This outcome measures the proportion of participants who meet the response criterion at Week 1.
Measured: Baseline and Week 1
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline. This outcome measures the proportion of participants who meet the response criterion at Week 2.
Measured: Baseline and Week 2
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline. This outcome measures the proportion of participants who meet the response criterion at Week 6.
Measured: Baseline and Week 6
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome measures the change in HAMA total score from baseline to Week 1.
Measured: Baseline and Week 1
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 2
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome measures the change in HAMA total score from baseline to Week 2.
Measured: Baseline and Week 2
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 6
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome measures the change in HAMA total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 1
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia. The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia. This outcome measures the change in SHAPS total score from baseline to Week 1.
Measured: Baseline and Week 1
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 2
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia. The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia. This outcome measures the change in SHAPS total score from baseline to Week 2.
Measured: Baseline and Week 2
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 6
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia. The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia. This outcome measures the change in SHAPS total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 1
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms. Higher scores indicate more severe psychosomatic symptoms. This outcome measures the change in PSSS total score from baseline to Week 1.
Measured: Baseline and Week 1
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 2
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms. Higher scores indicate more severe psychosomatic symptoms. This outcome measures the change in PSSS total score from baseline to Week 2.
Measured: Baseline and Week 2
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 6
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms. Higher scores indicate more severe psychosomatic symptoms. This outcome measures the change in PSSS total score from baseline to Week 6.
Measured: Baseline and Week 6
Incidence of Adverse Events
Adverse events will be recorded throughout the treatment and follow-up period. The number and proportion of participants experiencing adverse events will be summarized. The type, severity, duration, outcome, and relationship of adverse events to the intervention will be recorded.
Measured: From Day 1 through Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Model description
- Participants with major depressive disorder will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, or sham tTIS.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonggui Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yonggui Yuan, Zhongda Hospital
- Investigators
- Yonggui Yuan, PhD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612501
- Sponsor's protocol ID
- MR-32-25-078202
- Other IDs
- 82271570, BF2025611
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves sensitive mental health information and neuroimaging data. Data sharing may increase the risk of participant identification. De-identified data may be made available from the principal investigator upon reasonable request and with approval from the ethics committee, when permitted by applicable regulations and the informed consent.
Publications
Demchenko I, Rampersad S, Datta A, Horn A, Churchill NW, Kennedy SH, Krishnan S, Rueda A, Schweizer TA, Griffiths JD, Boyden ES, Santarnecchi E, Bhat V. Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial. Front Neurosci. 2024 Aug 29;18:1390250. doi: 10.3389/fnins.2024.1390250. eCollection 2024.
PubMed 39268031Grossman N, Okun MS, Boyden ES. Translating Temporal Interference Brain Stimulation to Treat Neurological and Psychiatric Conditions. JAMA Neurol. 2018 Nov 1;75(11):1307-1308. doi: 10.1001/jamaneurol.2018.2760. No abstract available.
PubMed 30264149
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression
- ClinicalTrials.gov ID
- NCT07612501
- Acronym / sponsor ID
- MR-32-25-078202
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Transcranial Temporal Interference Stimulation, Noninvasive Brain Stimulation, Anterior Limb of the Internal Capsule, Subgenual Anterior Cingulate Cortex, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonggui YuanUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 28 May 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 whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function.
The main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS.
Researchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment.
Participants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.
Detailed description
Major depressive disorder (MDD) is a common and disabling mental disorder. Although medication, psychotherapy, and established brain stimulation methods can help many people with MDD, some participants still have insufficient improvement. Transcranial temporal interference stimulation (tTIS) is a non-invasive brain stimulation technique that may allow modulation of deeper brain regions or pathways. This study is designed to evaluate whether tTIS can improve depressive symptoms in adults with MDD, assess its safety, and explore potential neuroimaging mechanisms.
This is a single-center, randomized, double-blind, sham-controlled clinical trial conducted at Zhongda Hospital, Southeast University. Eligible participants with MDD will be randomly assigned in a 1:1:1 ratio to one of three groups: active tTIS targeting the left anterior limb of the internal capsule (ALIC), active tTIS targeting the left subgenual anterior cingulate cortex (sgACC), or sham tTIS. The sham stimulation will be designed to provide sensory feedback similar to active stimulation while maintaining blinding.
Participants with MDD will receive 10 treatment sessions over 5 consecutive days, with two 20-minute sessions each day. Clinical symptoms and safety will be assessed at baseline, after treatment, and during follow-up. The main clinical outcome is the change in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline to after treatment. Secondary outcomes include follow-up changes in depressive symptoms, response and remission rates, anxiety symptoms, anhedonia, psychosomatic symptoms, side effects, and adverse events.
Multimodal 5.0T brain magnetic resonance imaging (MRI) will be collected from participants with MDD before and after treatment. MRI measures will include structural imaging, resting-state functional imaging, and diffusion imaging. These data will be used to explore changes in brain structure, functional connectivity, and diffusion-related measures after tTIS, and to identify potential imaging biomarkers related to treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants with major depressive disorder will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, or sham tTIS.
| Arm | Type | Receives |
|---|---|---|
| Active tTIS Targeting Left ALIC | Active comparator | Device: Active Transcranial Temporal Interference Stimulation Targeting Left ALICParticipants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions. |
| Active tTIS Targeting Left sgACC | Active comparator | Device: Active Transcranial Temporal Interference Stimulation Targeting Left sgACCParticipants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions. |
| Sham tTIS | Sham comparator | Device: Sham Transcranial Temporal Interference StimulationParticipants in this arm will receive sham transcranial temporal interference stimulation (tTIS). Sham stimulation will be delivered using the same type of device and will provide sensory feedback similar to active stimulation, but it will not provide the same active treatment dose. Treatment sessions will follow the same schedule as the active stimulation arms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists
- 24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline
- Aged 18 to 65 years
- Right-handed
- Able to understand the study procedures and willing to provide written informed consent
Key exclusion criteria (5 listed)
- History of epilepsy, brain tumor, or brain trauma
- Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months
- Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging
- Acute or severe suicidal ideation
- Any other condition judged by the investigators to make participation unsuitable for this study
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 |
|---|---|---|
| Active Transcranial Temporal Interference Stimulation Targeting Left ALICAlso: Active tTIS Targeting Left ALICParticipants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions. | Device | Active tTIS Targeting Left ALIC |
| Active Transcranial Temporal Interference Stimulation Targeting Left sgACCAlso: Active tTIS Targeting Left sgACCParticipants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions. | Device | Active tTIS Targeting Left sgACC |
| Sham Transcranial Temporal Interference StimulationAlso: Sham tTISParticipants in this arm will receive sham transcranial temporal interference stimulation (tTIS) using the same type of device as active stimulation. Sham stimulation will provide sensory feedback similar to active stimulation to help maintain masking, but it will not deliver the same active treatment dose. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions. | Device | Sham tTIS |
Primary outcome
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1
Time frame: Baseline and Week 1
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess the severity of depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. The primary outcome is the change in HAMD-24 total score from baseline to Week 1.
18 secondary outcomes
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 2
Time frame: Baseline and Week 2
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 6
Time frame: Baseline and Week 6
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Time frame: Week 1
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Time frame: Week 2
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
Time frame: Week 6
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Time frame: Baseline and Week 1
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Time frame: Baseline and Week 2
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
Time frame: Baseline and Week 6
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1
Time frame: Baseline and Week 1
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 1
Time frame: Baseline and Week 1
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 1
Time frame: Baseline and Week 1
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 6
Time frame: Baseline and Week 6
Incidence of Adverse Events
Time frame: From Day 1 through Week 6
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 28 May 2026.
- Results publication: PubMed 39268031Demchenko I, Rampersad S, Datta A, Horn A, Churchill NW, Kennedy SH, Krishnan S, Rueda A, Schweizer TA, Griffiths JD, Boyden ES, Santarnecchi E, Bhat V. Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial. Front Neurosci. 2024 Aug 29;18:1390250. doi: 10.3389/fnins.2024.1390250. eCollection 2024.
- Results publication: PubMed 30264149Grossman N, Okun MS, Boyden ES. Translating Temporal Interference Brain Stimulation to Treat Neurological and Psychiatric Conditions. JAMA Neurol. 2018 Nov 1;75(11):1307-1308. doi: 10.1001/jamaneurol.2018.2760. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study involves sensitive mental health information and neuroimaging data. Data sharing may increase the risk of participant identification. De-identified data may be made available from the principal investigator upon reasonable request and with approval from the ethics committee, when permitted by applicable regulations and the informed consent.
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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.
Yonggui Yuan, PhD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Temporal Interference Stimulation Targeting Left ALIC and Active Transcranial Temporal Interference Stimulation Targeting Left sgACC in people with Major Depressive Disorder (MDD), run by Yonggui Yuan 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 May 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?
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 Yue Zhou, MD Candidate (+86 15651003002, 2725106172@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1 (time frame: Baseline and Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07612501, which also lists 2 linked publications.
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 28 May 2026.