In this study, patients diagnosed with a depressive syndrome and with a clinical indication for treatment will receive an acute course of transcranial magnetic stimulation (TMS). The treatment consists of 20 TMS sessions administered over a period of four weeks (five sessions per week).
Magnetic resonance imaging (MRI) will be performed at four time points: prior to the start of treatment, after 10 treatment sessions, after completion of all 20 sessions, and at a three-month follow-up after the end of treatment. The MRI data will include different imaging modalities to assess treatment-related neurobiological changes.
The primary objective is to investigate changes in neuroimaging markers over the course of TMS treatment and to examine their associations with clinical response and behavioral as well as clinical outcome measures. Another key goal of the study is the identification of markers allowing for early prediction of treatment response to TMS and, additionally, for the prediction of relapse at follow-up.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
Age 18 years or older
Clinical indication for non-invasive brain stimulation due to a depressive episode (e.g., unipolar or bipolar depression) or predominant depression-associated symptoms (e.g., negative symptoms in schizophrenia-spectrum disorders)
Insufficient response to first-line treatments and/or patient preference for brain stimulation treatment
Capacity and willingness to provide written informed consent
Exclusion Criteria:
Acute suicidal risk
Presence of a significant neurological disorder or condition, including:
Increased intracranial pressure
Space-occupying brain lesions
History of cerebrovascular accident within the last 12 months
Incidental structural brain abnormalities on MRI requiring further diagnostic clarification
For TMS specifically:
Non-removable ferromagnetic implants in or near the stimulation site (e.g., cochlear implants, implanted neurostimulators, metallic clips or nails)
Other treatment-relevant ferromagnetic implants (e.g., cardiac pacemakers)
Primary outcome measure(s)
Difference in imaging parameter trajectory between Responders and Non-Responders across multi-modal Tissue Parameter Maps. — From enrollment to the end of treatment (4 weeks). We aim to identify an imaging-based correlate for treatment response. Therefore, we will compare the dynamic of tissue parameter maps (TPMs) between Responders and Non-Responders.
We will realize this by employing a voxel-wise, flexible factorial statistical framework with two main independent variables, TIME and RESPONDER. TIME will reflect the timepoint of the scan (before treatment, during treatment, after treatment). RESPONDER will denote whether a participant is a reponder or not. The responder status will be defined via the difference in Montgomery-Åsberg Depression Rating Scale (MADRS) before and after treatment (cutoff at least 50% MADRS reduction).
The main outcome will be generated by testing for the interaction effect of TIME and RESPONDER. This will test for voxel values in which the longitudinal change is different between responders and non-responders.
This statistical framework will be the main framework for all modalities with voxel-based outcomes.
Trial sites (1)
Facility
City
Region
Status
University Hospital Technical University of Munich
München
Germany
Recruiting
More Technical University of Munich trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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