臨床研究等提出・公開システム

TMS Database Registry Consortium Research in Japan (TReC-J)

TMS Registry & Retrospective Analysis Research (TReC-J)

1560

The study population consists of patients who received transcranial magnetic stimulation (TMS) therapy at our institution and were registered in the institutional TMS treatment registry. Background information to be collected for each participant includes demographic characteristics such as age, sex, handedness, educational attainment, and employment status. Clinical information will also be obtained, including the primary psychiatric diagnosis, comorbid psychiatric conditions, duration of illness, past psychiatric and medical history, medication history, and the presence of physical or neurological comorbidities. In addition, data pertaining to TMS treatment, such as stimulation protocols, treatment duration, treatment response, major clinical rating scales (e.g., depressive, anxiety, and functional assessments), and adverse events, will be collected to the extent that such information is available in the medical records.

The participant flow for this retrospective observational study is as follows. All individuals who received transcranial magnetic stimulation (TMS) therapy at our institution during the designated study period were screened for eligibility based on predefined inclusion criteria. Patients who met these criteria and were registered in the institutional TMS treatment registry were identified as eligible participants. Retrospective data were then extracted from electronic medical records and TMS treatment documentation for all eligible cases. After data extraction, records were anonymized and assessed for completeness and consistency.

The study is a retrospective observational analysis utilizing existing clinical records and TMS treatment documentation; therefore, no new interventions were introduced, and no cases of illness, injury, or other health-related adverse outcomes attributable to the conduct of the study occurred.

There has been no separate publication of analyses or results regarding the primary or secondary outcomes using the full registry dataset. However, as a principal product of this research, we have published the peer-reviewed English article, TMS Database Registry Consortium Research Project in Japan for Future Personalized Psychiatry.

The article outlines the nationwide TMS registry study (TReC-J), which aims to systematically collect and integrate epidemiological, clinical, cognitive, neuroimaging, and stimulation-parameter data from patients receiving TMS across diverse medical institutions in Japan. By centrally managing these anonymized multi-site data on a secure cloud platform, the project seeks to establish a research infrastructure that enables elucidation of the mechanisms of TMS for treatment-resistant depression.

Mar. 31, 2026

May. 22, 2022

https://www.mdpi.com/2075-4426/12/5/844

Yes

IPD sharing is available to investigators from the collaborating institutions that are members of the Clinical TMS Research Society and that are participating in the TMS Database Registry Study.

https://jrct.mhlw.go.jp/latest-detail/jRCT1050210059

Mimura Masaru

Keio University Hospital

35 Shinanomachi, Shinjuku, Tokyo

mimura@a7.keio.jp

Noda Yoshihiro

Keio University Hospital

35 Shinanomachi, Shinjuku, Tokyo

+81-3-3353-1211

yoshi-tms@keio.jp

Complete

Aug. 05, 2021

Observational

1) Currently receiving or planning to receive TMS therapy, regardless of whether it is covered by insurance, private practice, or clinical research.
2) Age 18 years and older at the time of obtaining consent.
3) Written consent for participation in the study has been obtained from the research subject or a substitute.

Consent by a substitute will only be required if the research participant is a minor or has cognitive impairment.
However, in the case of patients who have received TMS treatment in the past and cannot be contacted for explanation and consent, the data can be used after giving them the opportunity to refuse secondary use of the data by publishing an opt-out document on the website of the study period (Appendix 4: Opt-out document). In this case, "age at the time of obtaining consent" in selection criterion 2) should be replaced with "age at the time of (starting) TMS treatment.

1) Those whom the investigators consider unable to complete the planned treatment at any point prior to the start of TMS therapy.
2) Those whom the investigators judge that TMS therapy is not effective for the study subjects.
3) Patients with any of the following complications:
- Organic brain disease (e.g., intracranial organic lesions of moderate severity or more, neurodegenerative disease)
- Substance-related disorders in the 6 months prior to the start of TMS treatment
- Serious or unstable physical illness.
4) Patients with a history of any of the following:
Seizures or epilepsy (except for febrile convulsions in childhood)
5) Others who have been judged by the principal investigators or co-investigators to be inappropriate as subjects in the data collection of this research.

Both

Major depressive disorder and other neuropsychiatric disorders

Depression, Bipolar depression, Schizophrenia, Autistic spectrum disorder, Obsessive-compulsive disorder, Mild cognitive impairment, Post-COVID-19 syndrome

We will collect the information on pathological conditions (disgnosis and comorbidity), background (e.g., present history, past history, and treatment history), various assessments (clinical assessment, cognitive examination, adverse events, and tolerability etc.), and conducted TMS parameters and TMS protocols in the TMS database registry.
In this registry study, specific evaluation items are not set in concrete terms, but are arbitrary evaluation items that are left to the autonomy of each facility.
It is assumed that background factors and treatment parameters that correlate with treatment effects will be explored, but specific assessment items have not been defined.
If specific evaluation items are determined during the course of the study, we plan to revise this research protocol and have it reviewed again by the Ethics Committee.

Same as primary endpoints.

+81-75-753-4680

May. 30, 2023

none