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

NCT06740747 | Recruiting

• 1 other identifier: 11473_BO_S_2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia Patients

Keywords

iTBS; intermittent theta-burst stimulation; negative symptoms; cognition; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change in negative symptoms

  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.

  From enrollment to the end of iTBS treatment

Secondary Outcomes (26)

• Change in negative symptoms at 4-week follow-up

  From enrollment to follow-up 4 weeks after the end of iTBS treatment

• Speech-gesture rating task

  From enrollment to the end of iTBS treatment

• Speech-gesture rating task at 4-week follow-up

  From enrollment to follow-up 4 weeks after the end of iTBS treatment

• Eye-Tracking Task

  From enrollment to the end of iTBS treatment

• Eye-Tracking Task at 4-week follow-up

  From enrollment to 4 weeks after the end of iTBS treatment

Study Arms (2)

iTBS

EXPERIMENTAL

Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex

Device: Intermittent theta-burst stimulation

Sham iTBS

SHAM COMPARATOR

Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex

Device: Sham intermittent theta-burst stimulation

Interventions

Intermittent theta-burst stimulation DEVICE

Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex

iTBS

Sham intermittent theta-burst stimulation DEVICE

Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex

Sham iTBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia (ICD-10: F20.-)
• Age: 18-65 years
• Ability to give informed consent
• Signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Rasmus Schülke, MD (Dr. med.)

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasmus Schülke, MD (Dr. med.)

CONTACT

+49 511 532 2039; schuelke.rasmus@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

DE (1)