Real-World NeuroModulate: Noninvasive brain stimulation for depressive syndromes at TUM
Official title: Real-World NeuroModulate: Investigating Non-Invasive Brain Stimulation for Neuropsychiatric Disorders at TUM
Run by Technical University of Munich · NCT07420322 · Data updated 2026-11-12
We will try a standard course of intermittent theta-burst TMS—20 sessions over four weeks—in adults with depressive syndrome to see if brain scans change and if those changes predict symptom improvement.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (München) |
| Status | Recruiting |
| Started | August 15, 2024 |
| Main results expected | July 15, 2026 |
| Study ends | August 15, 2026 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT07420322 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a clinical indication for noninvasive brain stimulation for a depressive episode, who have had insufficient response to first-line treatments or prefer TMS, and who can undergo MRI and give informed consent.
✕Probably not a fit
Patients with acute suicidal risk, significant neurological disorders, recent stroke, non-removable ferromagnetic implants, or other MRI contraindications are excluded and unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, naturalistic observational project follows adults receiving routine intermittent theta-burst stimulation (iTBS) to the left dorsolateral prefrontal cortex for a depressive syndrome. Participants receive 20 iTBS sessions over four consecutive weeks while multimodal MRI is acquired before treatment, after 10 sessions, after 20 sessions, and at a three-month follow-up. Clinical symptoms are measured at baseline, two weeks, four weeks, and follow-up with clinician-rated and self-report scales (MADRS, HDRS, BDI). The primary aim is to identify imaging markers that track treatment-related neurobiological change and to test whether early imaging changes predict clinical response or later relapse.
Why it matters
Potential benefit: If successful, the findings could help identify who is likely to benefit from TMS early in the course of treatment, enabling more personalized care and fewer ineffective treatments.
How similar studies have gone: Previous randomized and naturalistic studies show antidepressant effects of TMS/iTBS and have identified candidate imaging correlates of response, but robust, clinically useful early predictive biomarkers remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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University Hospital Technical University of Munich
München, Germany Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.