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Recruiting NCT07422844

Dynamic Network Response to TMS Treatment

— Observational MDD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: MDD. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression

Overview

This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment. Additionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment. Patients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.

Primary outcome measures

  • Pre-Post TMS Treatment Effect Measured by HAMD [Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)]
Secondary outcome measures (6)
  • Pre-Post TMS Treatment Effect Measured by MADRS [Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)]
  • Pre-Post TMS Treatment Effect Measured by IDS-C [Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)]
  • Pre-Post TMS Treatment Effect Measured by HAMA [Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)]
  • Pre-Post TMS Treatment Effect Measured by YMRS [Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)]
  • Pre-Post TMS Treatment Effect Measured by BDI-II [Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)]
  • Patient and Clinician expected treatment outcome [Time frame: pre-TMS treatment]

Eligibility criteria

Inclusion criteria

  • Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation.
  • Men and women will be included in a balanced ratio.
  • German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.

Exclusion criteria

  • Patients younger than 18 or older than 70 will be excluded
  • Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded.
  • Further exclusion criteria for participation are acute or chronic neurological diseases.
  • Patients who are pregnant will not be included in the study.
  • As we use app-based questionnaires, we cannot include participants without internet-enabled devices in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Germany · 1 center
  • Klinik für Psychiatrie, Psychosomatik und Psychotherapie — Frankfurt am Main

Identifiers

NCT: NCT07422844 · 2025-2352

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗