Dynamic Network Response to TMS Treatment

Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression

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.

Study Overview

• Status: Recruiting
• Conditions: MDD

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jonathan Repple, Prof. Dr. med.; Phone Number: +4917641633481; Email: repple@uni-frankfurt.de

Study Locations

• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60528
      • Recruiting
      • Klinik für Psychiatrie, Psychosomatik und Psychotherapie
      • Contact: Henry Staub; Phone Number: +4915118991015; Email: staub@med.uni-frankfurt.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-Post TMS Treatment Effect Measured by MADRS	Difference Score between pre-TMS and post-TMS on the Montgomery-Asberg Depression Rating Scale (MADRS). MADRS: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with higher sensitivity to change than the HAMD with 10 items (duration approx. 15 min). Higher scores reflect greater symptom intensity. A sum score of the 10 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 60. A sum score ≤ 6 indicates no depression. A sum score between 7-16 indicates mild depression. A sum score between 20-34 indicates moderate depression. A sum score ≥ 35 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)
Pre-Post TMS Treatment Effect Measured by IDS-C	Difference Score between pre-TMS and post-TMS on the Inventory of Depressive Symptomatology Clinician Rated (IDS-C). IDS-C: Standard interview for assessing current depressive symptoms with higher sensitivity to residual symptoms than the HAMD with 30 items. The sum score for interpretation is calculated using 28 of the 30 items. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 84. A sum score ≤ 13 indicates no depression. A sum score between 14-25 indicates mild depression. A sum score between 26-38 indicates moderate depression. A sum score ≥ 48 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)
Pre-Post TMS Treatment Effect Measured by HAMA	Difference Score between pre-TMS and post-TMS on the Hamilton Anxiety Rating Scale (HAMA). HAMA: Standard interview to assess the severity of anxiety symptoms (duration approx. 5 min). Higher scores reflect greater symptom severity. A sum score of the 14 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 56. A sum score ≤ 17 indicates mild severity. A sum score between 18-24 indicates mild severity. A sum score between 25-30 indicates moderate to severe. A sum score ≥ 31 indicates severe to very severe.	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	Difference Score between pre-TMS and post-TMS on the Young Mania Rating Scale (YMRS). YMRS: Standard interview for assessing manic symptoms (duration approx. 10 min). Higher scores reflect greater symptom intensity. A sum score of the 11 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 60. A sum score ≤ 12 indicates no or minimal manic symptoms. A sum score between 13-19 indicates mild mania or hypomania. A sum score between 20-25 indicates moderate mania. A sum score ≥ 26 indicates severe mania.	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	Difference Score between pre-TMS and post-TMS on the Beck Depression Inventory Version 2 (BDI-II). BDI-II: Standard self-report questionnaire for assessing the severity of current depressive symptoms (duration approx. 4 min). Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 63. A sum score of the 21 items is calculated for interpretation: A sum score ≤ 13 indicates no or minimal depression. A sum score between 14-19 indicates mild depression. A sum score between 20-28 indicates moderate depression. A sum score ≥ 29 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)
Patient and Clinician expected treatment outcome	PATHEV questionnaire for patients once before treatment. Expectancy questionnaire for clinician on treatment effect for the patient. Scores on three sub-scales of the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV). PATHEV: Standard questionnaire to evaluate treatment effect expectations (duration approx 3 min). Higher scores on the sub-scales indicate hope of improvement, fear of change and treatment fit. The sub-scales consist of 4, 3 and 4 items. The sum scores range between a minimum of 11 and a maximum of 55.	pre-TMS treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom data during treatment	18 items on depressive symptoms asked daily via App once a day. The items are a subset of clinically relevant items used in the central DYNAMIC project (DRKS00038256) for daily App assessment. Higher scores reflect greater symptom severity.	daily over the course of treatment with TMS (4-6 weeks)

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: University of Giessen; Philipps Universität Marburg

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: TMS; Brain Networks; Symptom Networks
• Other Study ID Numbers: 2025-2352