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

Last updated: July 16, 2025
Sponsor: Hannover Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

Intermittent theta-burst stimulation

Sham intermittent theta-burst stimulation

Clinical Study ID

NCT06740747
11473_BO_S_2024
  • Ages 18-65
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of schizophrenia (ICD-10: F20.-)

  • Age: 18-65 years

  • Ability to give informed consent

  • Signed informed consent form

Exclusion

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 examinationsor make the MRI scanning cause additional burden

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Intermittent theta-burst stimulation
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Hannover Medical School

    Hannover, Niedersachsen 30625
    Germany

    Active - Recruiting

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