Major Depressive Disorder (MDD)NCT06385405
Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment
A study testing Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment and 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC) in people with Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment and 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to May 2026
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The diagnosis of participants should be made in accordance to the diagnostic criteria described for Major Depressive Disorder (MDD) of the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V).
- be willing to receive neuromodulation therapy and sign the written informed consent
- an age of 16-65 years
- The patient's medication regimen is based on only one antidepressant, and the medication regimen is not adjusted as much as possible during the treatment period.
- Having a total score of not less than 20 on the Hamilton Depression Rating Scale (HAMD-24).
- sufficient hearing or reading ability
Who cannot join
- History of electroconvulsive therapy (ECT)
- Presence of metallic foreign bodies near the stimulation coil or stimulation scalp, e.g., intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers)
- Epilepsy
- Pregnancy
- History of head injury
- Mental disorders such as schizophrenia, bipolar disorder, schizoid personality disorder, alcohol/drug abuse or dependence, etc.
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- Serious physical illnesses
- Taking medication that lowers the seizure threshold
- Participating in any clinical trial within 30 days before the baseline
- Other situations judged by the investigators not to be suitable for the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
TianHong Zhang, Doctor, 13127577024, zhang_tianhong@126.com
About this study
Official title: Repetitive Transcranial Magnetic Stimulation(rTMS) Treatment Based on Personalized Modulation of Electroencephalography Promotes Symptom Remission in Major Depressive Disorder (MDD) - A Randomized Controlled Clinical Trial
This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD).
Read the detailed description
Major depression disorder (MDD) is increasingly conceptualized as a disorder of brain networks, which related to dysregulation of functional connectivity. rTMS has the advantages of being safe, non-invasive and well-tolerated, and has been clarified by the FDA to be used in the treatment of depression with some positive efficacy. Machine learning based on EEG data, exploring machine learning and big data analytics methods, and applying the output reference value recommendations to the personalized treatment of depressed patients are expected to be more effective in promoting the alleviation of patients' depressive symptoms.
Every participant meeting the inclusion criteria will be fully informed of the study and be asked to sign the written informed consent before enrollment. Outpatient physicians will conduct the initial screening, collecting all diagnostic and medication information from the medical records at each follow-up visit. Several psychiatrists, all of whom are qualified and well-trained, will conduct clinical assessments at baseline and follow-up at the end of weekly TMS treatments, as well as clinical follow-up 3 months after the end of treatment. Clinical assessments will include HAMD, HAMA, CGI scale and etc. EEG parameter assessments will include changes in alpha-band spectral connectivity at baseline and after every 5 TMS treatments.
During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC). The treatments will be administered once a day, 5 times a week for 4 weeks, totaling 20 sessions. At the end of each week's treatment the patient's EEG will be recorded and the patient will be clinically evaluated by a qualified and well-trained psychiatrist. The original medication regimen will be maintained as much as possible during the treatment period, and adverse effects such as headaches will be faithfully recorded.
The sample size calculation for this study was based on a priori power analysis using G*Power 3.1.9.7. Among the imputed parameters it was chosen to include α = 0.05, power (1-ß) = 0.9. We used effect size f = 0.2 as parameter for the effect size estimation, based on the findings from previous study reported that the depressive symptom changes before and after rTMS intervention in patients with MDD. Two groups, corresponding to the two experimental conditions of the study, and age, sex, educational level, symptom, in total of 4 covariates were included. Taking into account a dropout rate of 15%, the final estimated number of participants is 70.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment, 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)
- Keywords
- Transcranial magnetic stimulation(TMS), electroencephalogram (EEG), Personalized treatment, machine learning
- 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.
Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) TreatmentDevice
The target site for alpha frequency Transcranial Magnetic Stimulation (αTMS) was identified based on alterations in alpha band spectral connectivity, which were measured using four frontal electroencephalography (EEG) channels (F1, F3, F5, FC3) subsequent to 10Hz transcranial magnetic stimulation (TMS). Alpha band spectral connectivity refers to the degree of similarity between the spectral waveforms of the alpha band across channels. The alpha frequency stimulation rate was defined as the highest spectral peak within the alpha band ranging from 7 to 13 Hz of the target channel. Each treatment cycle consisted of 20 daily sessions over a 4-week span, and stimulation was administered for 2 seconds every minute for a total duration of 20 minutes at 80% of the individual's motor threshold.
10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)Device
Prefrontal Transcranial Magnetic Stimulation (TMS) therapy repeated daily over 4 weeks (20 sessions) is US Food and Drug Administration (FDA) approved for treating Major Depressive Disorder in adults who have not responded to prior antidepressant medications. The strongest evidence supports high-frequency treatment over the left dorsolateral prefrontal cortex (DLPFC). The common stimulation frequency is 10Hz. It is usually applied for a duration of 4 weeks, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| The Precision Group | Experimental | Patients in the precision group will be treated with Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment. Receives: Device: Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment |
| The Conventional Group | Active comparator | Patients in the conventional group will be treated with 10Hz-frequency TMS over the left dorsolateral prefrontal cortex (DLPFC). Receives: Device: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the response rate
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the response rate is defined as a 30% decrease in HAMD score from those measured at baseline.
Measured: 4 weeks
Secondary outcomes (3)
complete remission rate
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the complete remission rate is defined as the HAMD score of less than 8 at the follow-up point.
Measured: 4 weeks
alpha band spectral connectivity in electroencephalogram (EEG) parameters
It will be determined by the changes of alpha band spectral connectivity in EEG parameters. Specifically, the EEG index is the change in alpha band spectral connectivity before and after a single TMS intervention, representing the functional connectivity between the frontal lobe and other brain regions across the entire brain.
Measured: 4 weeks
Evaluation of therapeutic effect
It will be determined using the criteria for the global improvement(GI) from Clinical Global Impression(CGI). Specifically, the global improvement(GI) will be rated by the clinician for the degree of improvement in the subject's current condition compared to baseline at enrollment on an 8-point scale from 0-7(the rating "1" refers to significant progress, and the rating "2" refers to progress, etc.).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start27 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Shanghai Municipal Science and Technology Commission, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Tianhong ZHANG, Shanghai Mental Health Center
- Investigators
- TianHong Zhang, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385405
- Sponsor's protocol ID
- 2024y0423
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation(rTMS) Treatment Based on Personalized Modulation of Electroencephalography Promotes Symptom Remission in Major Depressive Disorder (MDD) - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06385405
- Acronym / sponsor ID
- 2024y0423
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Transcranial magnetic stimulation(TMS), electroencephalogram (EEG), Personalized treatment, machine learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Shanghai Municipal Science and Technology Commission, Shanghai Jiao Tong University School of Medicine
- Study start
- 27 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Apr 2024 (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 study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD).
Detailed description
Major depression disorder (MDD) is increasingly conceptualized as a disorder of brain networks, which related to dysregulation of functional connectivity. rTMS has the advantages of being safe, non-invasive and well-tolerated, and has been clarified by the FDA to be used in the treatment of depression with some positive efficacy. Machine learning based on EEG data, exploring machine learning and big data analytics methods, and applying the output reference value recommendations to the personalized treatment of depressed patients are expected to be more effective in promoting the alleviation of patients' depressive symptoms.
Every participant meeting the inclusion criteria will be fully informed of the study and be asked to sign the written informed consent before enrollment. Outpatient physicians will conduct the initial screening, collecting all diagnostic and medication information from the medical records at each follow-up visit. Several psychiatrists, all of whom are qualified and well-trained, will conduct clinical assessments at baseline and follow-up at the end of weekly TMS treatments, as well as clinical follow-up 3 months after the end of treatment. Clinical assessments will include HAMD, HAMA, CGI scale and etc. EEG parameter assessments will include changes in alpha-band spectral connectivity at baseline and after every 5 TMS treatments.
During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC). The treatments will be administered once a day, 5 times a week for 4 weeks, totaling 20 sessions. At the end of each week's treatment the patient's EEG will be recorded and the patient will be clinically evaluated by a qualified and well-trained psychiatrist. The original medication regimen will be maintained as much as possible during the treatment period, and adverse effects such as headaches will be faithfully recorded.
The sample size calculation for this study was based on a priori power analysis using G*Power 3.1.9.7. Among the imputed parameters it was chosen to include α = 0.05, power (1-ß) = 0.9. We used effect size f = 0.2 as parameter for the effect size estimation, based on the findings from previous study reported that the depressive symptom changes before and after rTMS intervention in patients with MDD. Two groups, corresponding to the two experimental conditions of the study, and age, sex, educational level, symptom, in total of 4 covariates were included. Taking into account a dropout rate of 15%, the final estimated number of participants is 70.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC).
| Arm | Type | Receives |
|---|---|---|
| The Precision Group | Experimental | Device: Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) TreatmentPatients in the precision group will be treated with Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment. |
| The Conventional Group | Active comparator | Device: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)Patients in the conventional group will be treated with 10Hz-frequency TMS over the left dorsolateral prefrontal cortex (DLPFC). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The diagnosis of participants should be made in accordance to the diagnostic criteria described for Major Depressive Disorder (MDD) of the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V).
- be willing to receive neuromodulation therapy and sign the written informed consent
- an age of 16-65 years
- The patient's medication regimen is based on only one antidepressant, and the medication regimen is not adjusted as much as possible during the treatment period.
- Having a total score of not less than 20 on the Hamilton Depression Rating Scale (HAMD-24).
Key exclusion criteria (10 listed)
- History of electroconvulsive therapy (ECT)
- Presence of metallic foreign bodies near the stimulation coil or stimulation scalp, e.g., intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers)
- Epilepsy
- Pregnancy
- History of head injury
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 |
|---|---|---|
| Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) TreatmentThe target site for alpha frequency Transcranial Magnetic Stimulation (αTMS) was identified based on alterations in alpha band spectral connectivity, which were measured using four frontal electroencephalography (EEG) channels (F1, F3, F5, FC3) subsequent to 10Hz transcranial magnetic stimulation (TMS). Alpha band spectral connectivity refers to the degree of similarity between the spectral waveforms of the alpha band across channels. The alpha frequency stimulation rate was defined as the highest spectral peak within the alpha band ranging from 7 to 13 Hz of the target channel. Each treatment cycle consisted of 20 daily sessions over a 4-week span, and stimulation was administered for 2 seconds every minute for a total duration of 20 minutes at 80% of the individual's motor threshold. | Device | The Precision Group |
| 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)Prefrontal Transcranial Magnetic Stimulation (TMS) therapy repeated daily over 4 weeks (20 sessions) is US Food and Drug Administration (FDA) approved for treating Major Depressive Disorder in adults who have not responded to prior antidepressant medications. The strongest evidence supports high-frequency treatment over the left dorsolateral prefrontal cortex (DLPFC). The common stimulation frequency is 10Hz. It is usually applied for a duration of 4 weeks, 5 days a week. | Device | The Conventional Group |
Primary outcome
the response rate
Time frame: 4 weeks
It will be determined by Hamilton Depression Scale(HAMD-24 item) score. Specifically, the response rate is defined as a 30% decrease in HAMD score from those measured at baseline.
3 secondary outcomes
complete remission rate
Time frame: 4 weeks
alpha band spectral connectivity in electroencephalogram (EEG) parameters
Time frame: 4 weeks
Evaluation of therapeutic effect
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TianHong Zhang, Doctor principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment and 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC) in people with Major Depressive Disorder (MDD), 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TianHong Zhang, Doctor (13127577024, zhang_tianhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the response rate (time frame: 4 weeks). 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 6 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.