Real-World NeuroModulate: Investigating Non-Invasive Brain Stimulation for Neuropsychiatric Disorders at TUM

Summary

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

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)

Conditions2

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