TMS Registry & Retrospective Analysis Research

JRCT ID: jRCT1050210059

Registered date:05/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major depressive disorder and other neuropsychiatric disorders
• Date of first enrollment: 05/08/2021
• Target sample size: 4800
• Study type: Observational

Outcome(s)

Primary Outcome

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.

• Secondary Outcome: Same as primary endpoints.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Mimura Masaru