Major Depressive Disorder (MDD)NCT07533773
Investigating Functional Changes in the Frontotemporal Cortex of Patients With Major Depressive Disorder Following Electroconvulsive Therapy or Magnetic Seizure Therapy Using Functional Near-infrared Spectroscopy (fNIRS)
A study testing Electroconvulsive Therapy and Magnetic Seizure Therapy in people with Major Depressive Disorder (MDD), run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
Against the clinical backdrop of the growing global burden of neuropsychiatric disorders, the rapid rise in depression prevalence, and the frequent association of these conditions with cognitive impairment, this study highlights the limitations of current cognitive assessment tools-such as their time-consuming nature… Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Electroconvulsive Therapy and Magnetic Seizure Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Apr 2029
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A depressive episode diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by two psychiatrists;
- Meets the treatment criteria for ECT or MST;
- At least 5 years of education, with no significant hearing or visual impairments;
- Voluntary participation in this study, with a signed written informed consent form, and willingness to cooperate with the collection of general demographic information, neuropsychological testing, and fNIRS resting-state and task-based data acquisition.
Who cannot join
- Co-occurring mental disorders (such as substance use disorders or schizoaffective disorder);
- Severe physical illness;
- History of neurological disorders (such as traumatic brain injury or dementia);
- Low educational attainment;
- Receipt of ECT or MST treatment within the past six months.
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
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Nanxue Duan, +86-18326962052, 791909941@qq.com
About this study
Official title: Investigating Functional Changes in the Frontotemporal Cortex of Patients With Major Depressive Disorder Following Electroconvulsive Therapy or Magnetic Seizure Therapy Using Functional Near-infrared Spectroscopy
Against the clinical backdrop of the growing global burden of neuropsychiatric disorders, the rapid rise in depression prevalence, and the frequent association of these conditions with cognitive impairment, this study highlights the limitations of current cognitive assessment tools-such as their time-consuming nature and lack of specificity-and underscores the urgent need to develop simple and efficient assessment methods. In terms of treatment, modified electroconvulsive therapy (ECT) and magnetic seizure therapy (MST) are rapidly acting neuromodulation therapies; however, their effects on cognitive function and underlying brain mechanisms remain controversial, and there is a lack of direct comparative studies. Functional near-infrared spectroscopy (fNIRS) technology can non-invasively monitor changes in cerebral hemodynamics, providing a powerful tool for assessing brain function before and after treatment. Therefore, this study aims to combine resting-state and task-based fNIRS with multidimensional cognitive and emotional assessments to systematically compare the effects of ECT and MST on frontal-temporal cerebral hemodynamics. We seek to clarify the differences in brain function regulation between the two treatment modalities and their association with improvements in cognition and mood, with the goal of providing scientific evidence to elucidate the brain mechanisms underlying neurostimulation therapies and optimize individualized treatment plans.
Read the detailed description
The global burden of neuropsychiatric disorders continues to rise. Depression ranks among the leading causes of global disease burden as measured by years lived with disability, and its prevalence increased by more than 36% between 2010 and 2021. Depression manifests not only as core symptoms such as low mood and loss of interest but is also commonly accompanied by cognitive impairment, frequently presenting as declines in executive function, attention, memory, and information processing speed. The severity of these cognitive deficits directly impacts patients' treatment response, recovery of social functioning, and long-term prognosis, making them a key factor limiting patients' return to normal life.
However, there remains a significant gap in the clinical emphasis placed on and assessment of cognitive symptoms. Although existing cognitive assessment tools include subjective self-report questionnaires, individual neuropsychological tests, and battery tests, they generally have limitations: some tools are time-consuming and difficult to adapt to the needs of rapid clinical screening; others lack sufficient clinical evidence and normative data to support their use, resulting in insufficient diagnostic specificity and an inability to accurately match the cognitive impairment characteristics of different neuropsychiatric disorders. Therefore, in conjunction with advancements in neuroscience and technology, the development of simple, efficient, and specific cognitive assessment tools and brain function monitoring methods has become an urgent clinical need.
In the therapeutic field, neurostimulation therapies have gradually emerged as an important complement to pharmacotherapy and cognitive-behavioral therapy. Among these, modified electroconvulsive therapy (ECT) and magnetic seizure therapy (MST) are widely used in the treatment of depression due to their rapid onset of action and significant efficacy. As a classic neurostimulation method, ECT can rapidly alleviate depressive symptoms, particularly suicidal ideation; however, its short-term effects on cognitive function and the underlying brain mechanisms remain controversial. MST, on the other hand, induces localized cortical epileptiform discharges through rapidly changing magnetic fields and is characterized by high targeting precision; however, its safety profile and modulatory effects on brain function require further investigation. Yet, most studies in this field focus on a single treatment modality, lack sufficient comparative analysis of brain functional changes between resting and task states, and, more critically, lack direct comparative studies between ECT and MST.
The development of functional near-infrared spectroscopy (fNIRS) technology provides a powerful tool for addressing these issues. By monitoring changes in the concentrations of oxygenated and deoxygenated hemoglobin, this technology can non-invasively and in real-time reflect regional cerebral blood flow and functional activation levels, making it particularly suitable for assessing dynamic changes in brain function during cognitive tasks. Existing fNIRS studies have confirmed that in patients with depression, the oxygenated hemoglobin response in the prefrontal cortex is significantly lower than that in healthy controls during verbal fluency tasks and working memory N-back tasks, and this abnormality is associated with the severity of depression. During ECT treatment, the oxygenated hemoglobin response in the prefrontal cortex may further decrease; however, the correlation between this change and improvements in mood or cognitive function remains unclear. Furthermore, existing studies have primarily focused on task-based brain function analysis, with limited attention paid to changes in cerebral hemodynamics during rest before and after neurostimulation treatments, and a lack of systematic comparisons between the effects of ECT and MST on frontal-temporal lobe brain function.
Against this backdrop, this study focuses on the effects of ECT and MST on fronto-temporal cerebral hemodynamics. Through a dual-dimensional assessment of both resting-state and task-state conditions, combined with fNIRS technology and multidimensional cognitive and emotional assessment tools, the study aims to clarify the differences in the regulation of fronto-temporal brain function between the two treatment modalities and to reveal the associations between pre- and post-treatment changes in cerebral hemodynamics and improvements in cognitive function and emotional symptoms. The findings will provide new evidence for elucidating the neural mechanisms underlying neurostimulation therapies, offer a scientific basis for optimizing treatment protocols and developing personalized treatment strategies, and ultimately contribute to improving treatment outcomes and patient prognosis for neuropsychiatric disorders.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Electroconvulsive Therapy, Magnetic Seizure Therapy
- Keywords
- Major Depressive Disorder, Electroconvulsive Therapy, Magnetic Seizure Therapy, Functional Near-Infrared Spectroscopy
- 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.
Electroconvulsive TherapyOther
Electroconvulsive therapy will be administered 2 to 3 times per week according to a standardized protocol. Stimulation parameters-including intensity, target site, number of sessions, and duration-will be individually tailored for each participant based on prior research to ensure targeted and safe delivery within established safety parameters. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Magnetic Seizure TherapyOther
Magnetic seizure therapy will be administered 2 to 3 times per week according to a standardized protocol. Stimulation parameters-including intensity, target location, number of sessions, and duration-will be individually tailored for each participant based on prior research to ensure targeted and safe delivery within established safety parameters. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| ECT group | Active comparator | The patient will undergo at least three sessions of electroconvulsive therapy (ECT). Receives: Other: Electroconvulsive Therapy |
| MST group | Active comparator | The patient will undergo at least three sessions of magnetic seizure therapy (MST). Receives: Other: Magnetic Seizure Therapy |
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 clinician-administered 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
Differences in frontal and temporal lobe function during cognitive tasks in patients with depression following seizure therapy.
Functional near-infrared spectroscopy (fNIRS) was used to measure hemodynamic responses in the frontal and temporal lobes of patients with depression undergoing electroconvulsive therapy (ECT) or magnetic seizure therapy (MST). Test tasks included a category verbal fluency task (VFT) and a Go/No-Go task.
Measured: baseline and immediately after the intervention
Secondary outcomes (3)
Self-Rating Depression Scale
Self-Rating Depression Scale (SDS) comprises 20 items with a total score range of 0-100; higher scores indicate more severe depressive symptoms
Measured: Baseline and immediately after intervention
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAMA) comprises 14 items with a total score range of 0-56; higher scores indicate more severe anxiety symptoms
Measured: Baseline and immediately after intervention
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15) comprises 15 items with a total score of 30; higher scores indicate more severe somatization symptoms
Measured: Baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start30 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanghua Tian, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533773
- Sponsor's protocol ID
- AHMU-FNIRS-MDD
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 17 Jul 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Functional Changes in the Frontotemporal Cortex of Patients With Major Depressive Disorder Following Electroconvulsive Therapy or Magnetic Seizure Therapy Using Functional Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT07533773
- Acronym / sponsor ID
- AHMU-FNIRS-MDD
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Electroconvulsive Therapy, Magnetic Seizure Therapy, Functional Near-Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 16 Apr 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.
Against the clinical backdrop of the growing global burden of neuropsychiatric disorders, the rapid rise in depression prevalence, and the frequent association of these conditions with cognitive impairment, this study highlights the limitations of current cognitive assessment tools-such as their time-consuming nature and lack of specificity-and underscores the urgent need to develop simple and efficient assessment methods. In terms of treatment, modified electroconvulsive therapy (ECT) and magnetic seizure therapy (MST) are rapidly acting neuromodulation therapies; however, their effects on cognitive function and underlying brain mechanisms remain controversial, and there is a lack of direct comparative studies. Functional near-infrared spectroscopy (fNIRS) technology can non-invasively monitor changes in cerebral hemodynamics, providing a powerful tool for assessing brain function before and after treatment. Therefore, this study aims to combine resting-state and task-based fNIRS with multidimensional cognitive and emotional assessments to systematically compare the effects of ECT and MST on frontal-temporal cerebral hemodynamics. We seek to clarify the differences in brain function regulation between the two treatment modalities and their association with improvements in cognition and mood, with the goal of providing scientific evidence to elucidate the brain mechanisms underlying neurostimulation therapies and optimize individualized treatment plans.
Detailed description
The global burden of neuropsychiatric disorders continues to rise. Depression ranks among the leading causes of global disease burden as measured by years lived with disability, and its prevalence increased by more than 36% between 2010 and 2021. Depression manifests not only as core symptoms such as low mood and loss of interest but is also commonly accompanied by cognitive impairment, frequently presenting as declines in executive function, attention, memory, and information processing speed. The severity of these cognitive deficits directly impacts patients' treatment response, recovery of social functioning, and long-term prognosis, making them a key factor limiting patients' return to normal life.
However, there remains a significant gap in the clinical emphasis placed on and assessment of cognitive symptoms. Although existing cognitive assessment tools include subjective self-report questionnaires, individual neuropsychological tests, and battery tests, they generally have limitations: some tools are time-consuming and difficult to adapt to the needs of rapid clinical screening; others lack sufficient clinical evidence and normative data to support their use, resulting in insufficient diagnostic specificity and an inability to accurately match the cognitive impairment characteristics of different neuropsychiatric disorders. Therefore, in conjunction with advancements in neuroscience and technology, the development of simple, efficient, and specific cognitive assessment tools and brain function monitoring methods has become an urgent clinical need.
In the therapeutic field, neurostimulation therapies have gradually emerged as an important complement to pharmacotherapy and cognitive-behavioral therapy. Among these, modified electroconvulsive therapy (ECT) and magnetic seizure therapy (MST) are widely used in the treatment of depression due to their rapid onset of action and significant efficacy. As a classic neurostimulation method, ECT can rapidly alleviate depressive symptoms, particularly suicidal ideation; however, its short-term effects on cognitive function and the underlying brain mechanisms remain controversial. MST, on the other hand, induces localized cortical epileptiform discharges through rapidly changing magnetic fields and is characterized by high targeting precision; however, its safety profile and modulatory effects on brain function require further investigation. Yet, most studies in this field focus on a single treatment modality, lack sufficient comparative analysis of brain functional changes between resting and task states, and, more critically, lack direct comparative studies between ECT and MST.
The development of functional near-infrared spectroscopy (fNIRS) technology provides a powerful tool for addressing these issues. By monitoring changes in the concentrations of oxygenated and deoxygenated hemoglobin, this technology can non-invasively and in real-time reflect regional cerebral blood flow and functional activation levels, making it particularly suitable for assessing dynamic changes in brain function during cognitive tasks. Existing fNIRS studies have confirmed that in patients with depression, the oxygenated hemoglobin response in the prefrontal cortex is significantly lower than that in healthy controls during verbal fluency tasks and working memory N-back tasks, and this abnormality is associated with the severity of depression. During ECT treatment, the oxygenated hemoglobin response in the prefrontal cortex may further decrease; however, the correlation between this change and improvements in mood or cognitive function remains unclear. Furthermore, existing studies have primarily focused on task-based brain function analysis, with limited attention paid to changes in cerebral hemodynamics during rest before and after neurostimulation treatments, and a lack of systematic comparisons between the effects of ECT and MST on frontal-temporal lobe brain function.
Against this backdrop, this study focuses on the effects of ECT and MST on fronto-temporal cerebral hemodynamics. Through a dual-dimensional assessment of both resting-state and task-state conditions, combined with fNIRS technology and multidimensional cognitive and emotional assessment tools, the study aims to clarify the differences in the regulation of fronto-temporal brain function between the two treatment modalities and to reveal the associations between pre- and post-treatment changes in cerebral hemodynamics and improvements in cognitive function and emotional symptoms. The findings will provide new evidence for elucidating the neural mechanisms underlying neurostimulation therapies, offer a scientific basis for optimizing treatment protocols and developing personalized treatment strategies, and ultimately contribute to improving treatment outcomes and patient prognosis for neuropsychiatric disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT group | Active comparator | Other: Electroconvulsive TherapyThe patient will undergo at least three sessions of electroconvulsive therapy (ECT). |
| MST group | Active comparator | Other: Magnetic Seizure TherapyThe patient will undergo at least three sessions of magnetic seizure therapy (MST). |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A depressive episode diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by two psychiatrists;
- Meets the treatment criteria for ECT or MST;
- At least 5 years of education, with no significant hearing or visual impairments;
- Voluntary participation in this study, with a signed written informed consent form, and willingness to cooperate with the collection of general demographic information, neuropsychological testing, and fNIRS resting-state and task-based data acquisition.
Key exclusion criteria (5 listed)
- Co-occurring mental disorders (such as substance use disorders or schizoaffective disorder);
- Severe physical illness;
- History of neurological disorders (such as traumatic brain injury or dementia);
- Low educational attainment;
- Receipt of ECT or MST treatment within the past six 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 |
|---|---|---|
| Electroconvulsive TherapyElectroconvulsive therapy will be administered 2 to 3 times per week according to a standardized protocol. Stimulation parameters-including intensity, target site, number of sessions, and duration-will be individually tailored for each participant based on prior research to ensure targeted and safe delivery within established safety parameters. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions. | Other | ECT group |
| Magnetic Seizure TherapyMagnetic seizure therapy will be administered 2 to 3 times per week according to a standardized protocol. Stimulation parameters-including intensity, target location, number of sessions, and duration-will be individually tailored for each participant based on prior research to ensure targeted and safe delivery within established safety parameters. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions. | Other | MST group |
Primary outcome
Change in Hamilton Depression Rating Scale (HAMD) Score
Time frame: baseline and immediately after the intervention
The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Differences in frontal and temporal lobe function during cognitive tasks in patients with depression following seizure therapy.
Time frame: baseline and immediately after the intervention
Functional near-infrared spectroscopy (fNIRS) was used to measure hemodynamic responses in the frontal and temporal lobes of patients with depression undergoing electroconvulsive therapy (ECT) or magnetic seizure therapy (MST). Test tasks included a category verbal fluency task (VFT) and a Go/No-Go task.
3 secondary outcomes
Self-Rating Depression Scale
Time frame: Baseline and immediately after intervention
Hamilton Anxiety Rating Scale
Time frame: Baseline and immediately after intervention
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire
Time frame: Baseline and immediately after 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 17 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy and Magnetic Seizure Therapy in people with Major Depressive Disorder (MDD), run by The Second Hospital of 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 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: looking for participants now, as of the sponsor's last update on 17 Jul 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?
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 Yanghua Tian (+86-13955188448, tianyh@ahmu.edu.cn), 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 17 Jul 2026.