Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Schizophrenia Patients
- Sponsor
- Hannover Medical School
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in negative symptoms
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Schülke, Rasmus Dr.
Principal Investigator
Hannover Medical School
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
- •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
Outcomes
Primary Outcomes
Change in negative symptoms
Time Frame: From enrollment to the end of iTBS treatment
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.
Secondary Outcomes
- 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)
- Therapy dropout rate(From the beginning of iTBS treatment to the end of iTBS treatment)
- Serious Adverse Events (SAEs)(From the beginning of iTBS treatment to the end of iTBS treatment)
- Self-reported depression: BDI-II(From enrollment to the end of iTBS-treatment)
- Inflammatory cytokines(From enrollment to the end of iTBS treatment)
- Inflammatory cytokines at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Self-reported depression at 4-week follow-up: BDI-II(From enrollment to 4 weeks after the end of iTBS-treatment)
- 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)
- Reading the Mind in the Eyes Test(From enrollment to 4 weeks after the end of iTBS treatment)
- Reading the Mind in the Eyes Test at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- N-Back Test(From enrollment to the end of iTBS treatment)
- N-Back Test at 4-week follow-up(From enrollment to the end of iTBS treatment)
- FMRI: Resting-state functional connectivity(From enrollment to the end of iTBS treatment)
- FMRI: Resting-state functional connectivity at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- FMRI: Task-related functional connectivity(From enrollment to the end of iTBS treatment)
- FMRI: Task-related functional connectivity at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Stimulation-associated perceptions(From the beginning of each iTBS stimulation to after the end of each iTBS stimulation)
- Self-rated gesture perception and production: BAG(From enrollment to the end of iTBS-treatment)
- Self-rated gesture perception and production at 4-week follow-up: BAG(From enrollment to 4 weeks after the end of iTBS-treatment)
- Epigenetic changes of neurotrophic and immunological factors(From enrollment to the end of iTBS treatment)
- Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Concentrations of markers of neuronal damage(From enrollment to the end of iTBS treatment)
- Concentrations of markers of neuronal damage at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)