Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
NCT ID: NCT06740747
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-08
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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iTBS
Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Intermittent theta-burst stimulation
Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Sham iTBS
Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Sham intermittent theta-burst stimulation
Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Interventions
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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
Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Eligibility Criteria
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Inclusion Criteria
* Age: 18-65 years
* Ability to give informed consent
* Signed informed consent form
Exclusion Criteria
* Non-MRI-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry)
* Non-TMS-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants)
* Claustrophobia
* Epilepsy
* History of traumatic brain injury within the last 3 months
* History of stroke
* Active central nervous system (CNS) infection
* History of CNS infection within the last 3 months
* Pregnancy
* Current drug, medication, or alcohol abuse
* Simultaneous participation in another clinical trial
* Planned changes in psychopharmacological medication within the next 2 weeks
* Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden
18 Years
65 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Schülke, Rasmus Dr.
Principal Investigator
Principal Investigators
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Rasmus Schülke, MD (Dr. med.)
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Hannover Medical School
Hanover, Lower Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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11473_BO_S_2024
Identifier Type: -
Identifier Source: org_study_id
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