Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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: * Receive 10 sessions of iTBS over the course of 2 weeks * Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Diagnosis of schizophrenia (ICD-10: F20.-)

• Age: 18-65 years

• Ability to give informed consent

• Signed informed consent form

Locations
Other Locations
Germany
Hannover Medical School
RECRUITING
Hanover
Contact Information
Primary
Rasmus Schülke, MD (Dr. med.)
schuelke.rasmus@mh-hannover.de
+49 511 532 2039
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: iTBS
Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Sham_comparator: Sham iTBS
Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Related Therapeutic Areas
Sponsors
Leads: Hannover Medical School

This content was sourced from clinicaltrials.gov