Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent theta-burst stimulation, Sham intermittent theta-burst stimulation.
- Who it may be relevant to
- Registry conditions: Schizophrenia Patients. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
Overview
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.
Interventions
- Device Intermittent theta-burst stimulation
Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex - Device Sham intermittent theta-burst stimulation
Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Primary outcome measures
- Change in negative symptoms [Time frame: From enrollment to the end of iTBS treatment]
Secondary outcome measures (12)
- Change in negative symptoms at 4-week follow-up [Time frame: From enrollment to follow-up 4 weeks after the end of iTBS treatment]
- Speech-gesture rating task [Time frame: From enrollment to the end of iTBS treatment]
- Speech-gesture rating task at 4-week follow-up [Time frame: From enrollment to follow-up 4 weeks after the end of iTBS treatment]
- Eye-Tracking Task [Time frame: From enrollment to the end of iTBS treatment]
- Eye-Tracking Task at 4-week follow-up [Time frame: From enrollment to 4 weeks after the end of iTBS treatment]
- Reading the Mind in the Eyes Test [Time frame: From enrollment to 4 weeks after the end of iTBS treatment]
- Reading the Mind in the Eyes Test at 4-week follow-up [Time frame: From enrollment to 4 weeks after the end of iTBS treatment]
- N-Back Test [Time frame: From enrollment to the end of iTBS treatment]
- N-Back Test at 4-week follow-up [Time frame: From enrollment to the end of iTBS treatment]
- FMRI: Resting-state functional connectivity [Time frame: From enrollment to the end of iTBS treatment]
- FMRI: Resting-state functional connectivity at 4-week follow-up [Time frame: From enrollment to 4 weeks after the end of iTBS treatment]
- FMRI: Task-related functional connectivity [Time frame: From enrollment to the end of iTBS treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Hannover Medical School — Hanover
Identifiers
NCT: NCT06740747 · 11473_BO_S_2024