Dynamic Network Response to TMS Treatment
ConditionMDD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorGoethe University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
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 outcomes
1
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.
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)2
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.
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)3
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.
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)4
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.
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)Other outcomes
1
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.
Time frame
daily over the course of treatment with TMS (4-6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Goethe University
Lead sponsor
Johann Wolfgang Goethe University Hospital
Sponsor institution
University of Giessen
Collaborator
Philipps Universität Marburg
Collaborator
Source ClinicalTrials.gov