Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia

NCT06740747 · tracked via the Priya Life Science Germany tracker

Sponsor

Hannover Medical School

Phase

Not applicable

Started

2025-04-08

Last updated

2026-09-18

Condition(s) studied

Schizophrenia Patients

Investigational drug(s) / intervention(s)

Intermittent theta-burst stimulationSham intermittent theta-burst stimulation

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

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Diagnosis of schizophrenia (ICD-10: F20.-) * Age: 18-65 years * Ability to give informed consent * Signed informed consent form Exclusion Criteria: * Any electronic implants * 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

Primary outcome measure(s)

Change in negative symptoms — From enrollment to the end of iTBS treatment
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.

Trial sites (1)

Facility	City	Region	Status
Hannover Medical School	Hanover	Lower Saxony	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740747 on ClinicalTrials.gov ↗ ← All trials in Germany