Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06740747

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hannover Medical School

Hanover, Lower Saxony, Germany, 30625

Actively Recruiting

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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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