Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06385405 |
| Other study ID # |
2024y0423 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2024 |
| Est. completion date |
May 2026 |
Study information
| Verified date |
June 2024 |
| Source |
Shanghai Mental Health Center |
| Contact |
TianHong Zhang, Doctor |
| Phone |
13127577024 |
| Email |
zhang_tianhong[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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).
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.
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