An interventional study of Intermittent theta-burst stimulation and Sham intermittent theta-burst stimulation in Schizophrenia Patients, sponsored by Hannover Medical School. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hannover Medical School · Not applicable, Interventional, and Treatment
The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session.
The goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is:
Does iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms.
Participants will:
The study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Device: Intermittent theta-burst stimulation
Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Device: Sham intermittent theta-burst stimulation
Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Change in negative symptoms
Change in negative symptoms, measured with the Clinical Assessment Interview for Negative Symptoms (CAINS). Higher CAINS scores correspond to more negative symptoms. The minimum total score is 0 points, the maximum total score is 52 points.
Time frame: From enrollment to the end of iTBS treatment
Change in negative symptoms at 4-week follow-up
Change in negative symptoms, measured with the Clinical Assessment Interview for Negative Symptoms (CAINS). Higher CAINS scores correspond to more negative symptoms. The minimum total score is 0 points, the maximum total score is 52 points.
Time frame: From enrollment to follow-up 4 weeks after the end of iTBS treatment
Speech-gesture rating task
Accuracy and speed of evaluations in the Speech-Gesture Rating Task.
Time frame: From enrollment to the end of iTBS treatment
Speech-gesture rating task at 4-week follow-up
Accuracy and speed of evaluations in the Speech-Gesture Rating Task at 4-week follow-up.
Time frame: From enrollment to follow-up 4 weeks after the end of iTBS treatment
Eye-Tracking Task
Changes in eye movements in the Eye-Tracking Task.
Time frame: From enrollment to the end of iTBS treatment
Eye-Tracking Task at 4-week follow-up
Changes in eye movements in the Eye-Tracking Task at 4-week follow-up.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Reading the Mind in the Eyes Test
Reading the Mind in the Eyes Test.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Reading the Mind in the Eyes Test at 4-week follow-up
Reading the Mind in the Eyes Test at 4-week follow-up.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
N-Back Test
Working memory performance in the N-Back Test (sensitivity index).
Time frame: From enrollment to the end of iTBS treatment
N-Back Test at 4-week follow-up
Working memory performance in the N-Back Test (sensitivity index) 4 weeks after the end of iTBS treatment.
Time frame: From enrollment to the end of iTBS treatment
FMRI: Resting-state functional connectivity
Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC.
Time frame: From enrollment to the end of iTBS treatment
FMRI: Resting-state functional connectivity at 4-week follow-up
Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
FMRI: Task-related functional connectivity
Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task.
Time frame: From enrollment to the end of iTBS treatment
FMRI: Task-related functional connectivity at 4-week follow-up
Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Inflammatory cytokines
Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva.
Time frame: From enrollment to the end of iTBS treatment
Inflammatory cytokines at 4-week follow-up
Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Stimulation-associated perceptions
Stimulation-associated perceptions, measured using the TMS Adverse Events and Associated Sensations Questionnaire (TMSensQ, Section IV), after each iTBS session.
Time frame: From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
Therapy dropout rate
Therapy dropout rate (i.e. study termination).
Time frame: From the beginning of iTBS treatment to the end of iTBS treatment
Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs), measured using TMSensQ (Section V).
Time frame: From the beginning of iTBS treatment to the end of iTBS treatment
Self-reported depression: BDI-II
Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points.
Time frame: From enrollment to the end of iTBS-treatment
Self-reported depression at 4-week follow-up: BDI-II
Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points.
Time frame: From enrollment to 4 weeks after the end of iTBS-treatment
Self-rated gesture perception and production: BAG
Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points.
Time frame: From enrollment to the end of iTBS-treatment
Self-rated gesture perception and production at 4-week follow-up: BAG
Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points.
Time frame: From enrollment to 4 weeks after the end of iTBS-treatment
Epigenetic changes of neurotrophic and immunological factors
Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors.
Time frame: From enrollment to the end of iTBS treatment
Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up
Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Concentrations of markers of neuronal damage
Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum.
Time frame: From enrollment to the end of iTBS treatment
Concentrations of markers of neuronal damage at 4-week follow-up
Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum.
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Plan to share: Undecided — Whether IPD may be shared has not yet been decided. IPD might not be shared due to data protection laws.
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