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IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition

RecruitingNAAges 18 Years - 65 YearsAllMax-Planck-Institute of Psychiatry
NCT07197138 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

This is a monocentric, randomized pilot study conducted at the Max Planck Institute of Psychiatry, Munich. The study investigates the effects of two different intermittent theta-burst stimulation (iTBS) schedules on biological and clinical outcomes in patients with depression and comorbid Post-COVID-19 condition (PCC). Participants will be randomized into two arms, both receiving a total of 30 active iTBS sessions applied to the left dorsolateral prefrontal cortex (DLPFC) at 90% resting motor threshold using a PowerMAG 100 ppTMS stimulator: * Standard Arm: One iTBS session per day, five days per week, over six weeks. * Intensified Arm: Six iTBS sessions per day, approximately one-hour apart, over five consecutive days. The primary outcomes are changes in immunological blood markers (C-reactive protein \[CRP\], tumor necrosis factor \[TNF\], interleukin-1ฮฒ \[IL-1ฮฒ\], interleukin-6 \[IL-

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18-65 years * Capacity to consent (legally competent, written informed consent including data protection) * Diagnosis of depression (at least moderate severity, BDI-II โ‰ฅ 20), including major depressive episode in bipolar disorder * Comorbid diagnosis of Post-COVID-19 condition (WHO definition) * Insufficient improvement of depressive symptoms under psychopharmacological treatment * Stable psychopharmacological medication for at least 4 weeks prior to start of iTBS Exclusion Criteria: * Age \<18 years or \>65 years * Pregnancy, planned pregnancy, or breastfeeding * Legal guardianship or cognitive impairment preventing valid informed consent * Severe developmental disorder or intellectual disability * Acute or chronic substance abuse (alcohol, prescription drugs, or illicit drugs) * Current treatment with benzodiazepines or Z-substances * Acute suicidality * Psychotic symptoms * Severe neurological disorder (e.g., major brain injury, neurodegenerative disease) * Ongoing treatment with another neurostimulation method (ECT, TMS, VNS) * Contraindications to TMS, including: Intracranial metal, implants, shunts, Cochlear implant, pacemaker, implantable defibrillator, History of seizures or epileptiform EEG * Severe general medical illness (e.g., anemia requiring transfusion, severe arrhythmias, cardiomyopathy)
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What it tests

  • Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS
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Where

1 site
Max-Planck-Institute of Psychiatry
Munich, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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