Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia (ITBS-NKS-2024)

Hannover Medical School (MHH)

Status: Enrolling

Conditions: Schizophrenia Patients

Treatments: Device: Intermittent theta-burst stimulation; Device: Sham intermittent theta-burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06740747

11473_BO_S_2024

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

iTBS

Experimental group

Description:

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

Treatment:

Device: Intermittent theta-burst stimulation

Sham iTBS

Sham Comparator group

Description:

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

Treatment:

Device: Sham intermittent theta-burst stimulation