Brain stimulation for depression-associated symptoms – a real-world clinical investigation of noninvasive brain stimulation treatments offered at the Department of Psychiatry and Psychotherapy of the LMU Hospital
- Conditions
- other: depressive symptoms of bipolar disorder, negative symptoms of schizophreniaHealthy volunteersF32Depressive episode
- Registration Number
- DRKS00024776
- Lead Sponsor
- Department of Psychiatry and Psychotherapy, LMU Hospital Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1300
Indication for NTBS treatment for a depressive episode as assessed by the clinical evaluation
- Patient preference for NTBS treatment
- Capable and willing to provide informed consent.
- Individuals with a substance abuse disorder or substance dependence (except nicotine, caffeine) in the last 6 months
- Individuals at suicidal risk
- Any relevant instable medical condition (e.g. acute, unstable cardiac disease)
- Individuals diagnosed with a significant neurological disorder or insult including, but not limited to:
oIncreased intracranial pressure
oSpace occupying brain lesion
oHistory of cerebrovascular accident
oTransient ischemic attack within two years
oCerebral aneurysm
oHuntington’s chorea
oMultiple sclerosis
oEpilepsy
- Individuals with a history of severe traumatic brain injury or status post brain/heart surgery
- In general, individuals with any history of seizures
- Individuals with significant anatomical abnormalities as seen on cerebral MRI
- Individuals with non-removable, ferromagnetic implants/material in proximity to application site (e.g. cochlear implant, implanted neurostimulators, nails, clips, etc.) or treatment-relevant ferromagnetic implants in other body parts (e.g. cardiac pacemaker)
- For tDCS specifically – severe skin disorders (e.g. psoriasis vulgaris) in proximity to application site
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression severity assessed by MADRS at the end of (acute) treatment
- Secondary Outcome Measures
Name Time Method BDI, HDRS, other clinical scales, cognitive performance, neuroimaging parameters