Clinical trial NCT06740747: Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
Official title: Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia Patients
Keywords: iTBS
intermittent theta-burst stimulation
negative symptoms
cognition
schizophrenia
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in negative symptoms
timeFrame: From enrollment to the end of iTBS treatment
Secondary outcomes:
measure: Change in negative symptoms at 4-week follow-up
timeFrame: From enrollment to follow-up 4 weeks after the end of iTBS treatment
measure: Speech-gesture rating task
timeFrame: From enrollment to the end of iTBS treatment
measure: Speech-gesture rating task at 4-week follow-up
timeFrame: From enrollment to follow-up 4 weeks after the end of iTBS treatment
measure: Eye-Tracking Task
timeFrame: From enrollment to the end of iTBS treatment
measure: Eye-Tracking Task at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: Reading the Mind in the Eyes Test
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: Reading the Mind in the Eyes Test at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: N-Back Test
timeFrame: From enrollment to the end of iTBS treatment
measure: N-Back Test at 4-week follow-up
timeFrame: From enrollment to the end of iTBS treatment
measure: FMRI: Resting-state functional connectivity
timeFrame: From enrollment to the end of iTBS treatment
measure: FMRI: Resting-state functional connectivity at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: FMRI: Task-related functional connectivity
timeFrame: From enrollment to the end of iTBS treatment
measure: FMRI: Task-related functional connectivity at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: Inflammatory cytokines
timeFrame: From enrollment to the end of iTBS treatment
measure: Inflammatory cytokines at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: Stimulation-associated perceptions
timeFrame: From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
measure: Therapy dropout rate
timeFrame: From the beginning of iTBS treatment to the end of iTBS treatment
measure: Serious Adverse Events (SAEs)
timeFrame: From the beginning of iTBS treatment to the end of iTBS treatment
measure: Self-reported depression: BDI-II
timeFrame: From enrollment to the end of iTBS-treatment
measure: Self-reported depression at 4-week follow-up: BDI-II
timeFrame: From enrollment to 4 weeks after the end of iTBS-treatment
measure: Self-rated gesture perception and production: BAG
timeFrame: From enrollment to the end of iTBS-treatment
measure: Self-rated gesture perception and production at 4-week follow-up: BAG
timeFrame: From enrollment to 4 weeks after the end of iTBS-treatment
measure: Epigenetic changes of neurotrophic and immunological factors
timeFrame: From enrollment to the end of iTBS treatment
measure: Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
measure: Concentrations of markers of neuronal damage
timeFrame: From enrollment to the end of iTBS treatment
measure: Concentrations of markers of neuronal damage at 4-week follow-up
timeFrame: From enrollment to 4 weeks after the end of iTBS treatment
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Niedersachsen
Study officials:
affiliation: Hannover Medical School
name: Rasmus Schülke, MD (Dr. med.)
role: PRINCIPAL_INVESTIGATOR
References: