Dynamic Network Response to TMS Treatment

NCT07422844 | Recruiting

• 1 other identifier: 2025-2352
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MDD

Keywords

TMS; Brain Networks; Symptom Networks

Outcome Measures

Primary Outcomes (1)

• Pre-Post TMS Treatment Effect Measured by HAMD

  Difference Score between pre-TMS and post-TMS on the Hamilton Depression Rating Scale (HAMD). HAMD: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with 17 and 4 additional items (duration approx. 20 min). For this outcome measure, the first 17 items are used to calculate a sum score for interpretation, because cut-off scores exist for the HAMD-17 version. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 52. A sum score ≤ 8 indicates no depression. A sum score between 9-16 indicates mild depression. A sum score between 17-24 indicates moderate depression. A sum score ≥ 25 indicates severe depression.

  Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)

Secondary Outcomes (6)

• Pre-Post TMS Treatment Effect Measured by MADRS

  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

  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

  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

  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

  Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)

Other Outcomes (1)

• Symptom data during treatment

  daily over the course of treatment with TMS (4-6 weeks)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Roughly 50 patients will be recruited at the study site in Frankfurt, 25 at the study site in Marburg and 25 at the study site in Gießen. Due to the observational nature of the study, the recruitment process is limited by the TMS treatment capacities of the University Clinics.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Goethe University: lead
• University of Giessen: collaborator
• Philipps Universität Marburg: collaborator

Study Sites (1)

Klinik für Psychiatrie, Psychosomatik und Psychotherapie

Frankfurt am Main, Hesse, 60528, Germany

RECRUITING

Central Study Contacts

Jonathan Repple, Prof. Dr. med.

CONTACT

+4917641633481; repple@uni-frankfurt.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 20, 2026
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

DE (1)