Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment

NCT06385405 | Recruiting

• 1 other identifier: 2024y0423
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Major Depressive Disorder (MDD)

Keywords

Transcranial magnetic stimulation(TMS); electroencephalogram (EEG); Personalized treatment; machine learning

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• complete remission rate

  4 weeks

• alpha band spectral connectivity in electroencephalogram (EEG) parameters

  4 weeks

• Evaluation of therapeutic effect

  4 weeks

Study Arms (2)

The Precision Group

EXPERIMENTAL

Patients in the precision group will be treated with Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment.

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).

Device: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)

Interventions

Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment DEVICE

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.

The Precision Group

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.

The Conventional Group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• National Natural Science Foundation of China: collaborator
• Shanghai Municipal Science and Technology Commission: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• TianHong Zhang, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TianHong Zhang, Doctor

CONTACT

13127577024; zhang_tianhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: May 27, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)