NCT07420322 Real-World NeuroModulate: Investigating Non-Invasive Brain Stimulation for Neuropsychiatric Disorders at TUM
| NCT ID | NCT07420322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | Depressive Syndrom |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-08-15 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Frequently Asked Questions
Who can join the NCT07420322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Syndrom. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07420322 currently recruiting?
Yes, NCT07420322 is actively recruiting participants. Visit ClinicalTrials.gov or contact Technical University of Munich to inquire about joining.
Where is the NCT07420322 trial being conducted?
This trial is being conducted at München, Germany.
Who is sponsoring the NCT07420322 clinical trial?
NCT07420322 is sponsored by Technical University of Munich. The trial plans to enroll 100 participants.