Actively Recruiting
Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
Led by Hannover Medical School · Updated on 2025-07-20
60
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia (ICD-10: F20.-)
- Age between 18 and 65 years
- Ability to provide informed consent
- Signed informed consent form
You will not qualify if you...
- Presence of any electronic implants
- Non-MRI-compatible metal implants such as pacemakers, cochlear implants, insulin pumps, metal fragments, or metal-processing industry work
- Non-TMS-compatible metal implants (earrings, piercings, dental fillings, crowns, implants are allowed)
- Claustrophobia
- Epilepsy
- Traumatic brain injury within the last 3 months
- History of stroke
- Active central nervous system infection
- Central nervous system infection within the last 3 months
- Pregnancy
- Current drug, medication, or alcohol abuse
- Participation in another clinical trial
- Planned changes in psychopharmacological medication within the next 2 weeks
- Severe physical illnesses that could endanger the patient, affect examinations, or add burden during MRI
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hannover Medical School
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
Research Team
R
Rasmus Schülke, MD (Dr. med.)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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