Schizophrenia PatientsITBS-NKS-2024NCT06740747
Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
A study testing Intermittent theta-burst stimulation in people with Schizophrenia Patients, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Patients
- What is being tested?
- Intermittent theta-burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia (ICD-10: F20.-)
- Age: 18-65 years
- Ability to give informed consent
- Signed informed consent form
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Rasmus Schülke, MD (Dr. med.), +49 511 532 2039, schuelke.rasmus@mh-hannover.de
Rasmus Schülke, MD (Dr. med.)
About this study
Official title: Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
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:
Read more
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
- Being tested
- Intermittent theta-burst stimulation, Sham intermittent theta-burst stimulation
- Keywords
- iTBS, intermittent theta-burst stimulation, negative symptoms, cognition, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta-burst stimulationDevice
Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Sham intermittent theta-burst stimulationDevice
Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| iTBS | Experimental | Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex Receives: Device: Intermittent theta-burst stimulation |
| Sham iTBS | Sham comparator | Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex Receives: Device: Sham intermittent theta-burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of iTBS treatment
Secondary outcomes (26)
Change in negative symptoms at 4-week follow-up
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.
Measured: From enrollment to follow-up 4 weeks after the end of iTBS treatment
Speech-gesture rating task
Accuracy and speed of evaluations in the Speech-Gesture Rating Task.
Measured: From enrollment to the end of iTBS treatment
Speech-gesture rating task at 4-week follow-up
Accuracy and speed of evaluations in the Speech-Gesture Rating Task at 4-week follow-up.
Measured: From enrollment to follow-up 4 weeks after the end of iTBS treatment
Eye-Tracking Task
Changes in eye movements in the Eye-Tracking Task.
Measured: From enrollment to the end of iTBS treatment
Eye-Tracking Task at 4-week follow-up
Changes in eye movements in the Eye-Tracking Task at 4-week follow-up.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
Reading the Mind in the Eyes Test
Reading the Mind in the Eyes Test.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
Reading the Mind in the Eyes Test at 4-week follow-up
Reading the Mind in the Eyes Test at 4-week follow-up.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
N-Back Test
Working memory performance in the N-Back Test (sensitivity index).
Measured: From enrollment to the end of iTBS treatment
N-Back Test at 4-week follow-up
Working memory performance in the N-Back Test (sensitivity index) 4 weeks after the end of iTBS treatment.
Measured: From enrollment to the end of iTBS treatment
FMRI: Resting-state functional connectivity
Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC.
Measured: From enrollment to the end of iTBS treatment
FMRI: Resting-state functional connectivity at 4-week follow-up
Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
FMRI: Task-related functional connectivity
Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task.
Measured: From enrollment to the end of iTBS treatment
FMRI: Task-related functional connectivity at 4-week follow-up
Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
Inflammatory cytokines
Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva.
Measured: From enrollment to the end of iTBS treatment
Inflammatory cytokines at 4-week follow-up
Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
Stimulation-associated perceptions
Stimulation-associated perceptions, measured using the TMS Adverse Events and Associated Sensations Questionnaire (TMSensQ, Section IV), after each iTBS session.
Measured: From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
Therapy dropout rate
Therapy dropout rate (i.e. study termination).
Measured: From the beginning of iTBS treatment to the end of iTBS treatment
Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs), measured using TMSensQ (Section V).
Measured: From the beginning of iTBS treatment to the end of iTBS treatment
Self-reported depression: BDI-II
Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points.
Measured: From enrollment to the end of iTBS-treatment
Self-reported depression at 4-week follow-up: BDI-II
Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points.
Measured: From enrollment to 4 weeks after the end of iTBS-treatment
Self-rated gesture perception and production: BAG
Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points.
Measured: From enrollment to the end of iTBS-treatment
Self-rated gesture perception and production at 4-week follow-up: BAG
Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points.
Measured: From enrollment to 4 weeks after the end of iTBS-treatment
Epigenetic changes of neurotrophic and immunological factors
Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors.
Measured: From enrollment to the end of iTBS treatment
Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up
Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
Concentrations of markers of neuronal damage
Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum.
Measured: From enrollment to the end of iTBS treatment
Concentrations of markers of neuronal damage at 4-week follow-up
Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum.
Measured: From enrollment to 4 weeks after the end of iTBS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start8 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schülke, Rasmus Dr., Hannover Medical School
- Investigators
- Rasmus Schülke, MD (Dr. med.), Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740747
- Sponsor's protocol ID
- 11473_BO_S_2024
- Acronym
- ITBS-NKS-2024
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Whether IPD may be shared has not yet been decided. IPD might not be shared due to data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
- ClinicalTrials.gov ID
- NCT06740747
- Acronym / sponsor ID
- ITBS-NKS-2024 / 11473_BO_S_2024
- Conditions
- Schizophrenia Patients
- Keywords
- iTBS, intermittent theta-burst stimulation, negative symptoms, cognition, schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTBS | Experimental | Device: Intermittent theta-burst stimulationActive intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex |
| Sham iTBS | Sham comparator | Device: Sham intermittent theta-burst stimulationSham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia (ICD-10: F20.-)
- Age: 18-65 years
- Ability to give informed consent
- Signed informed consent form
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta-burst stimulationIntermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex | Device | iTBS |
| Sham intermittent theta-burst stimulationSham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex | Device | Sham iTBS |
Primary outcome
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.
26 secondary outcomes
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
FMRI: Task-related functional connectivity at 4-week follow-up
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Inflammatory cytokines
Time frame: From enrollment to the end of iTBS treatment
Inflammatory cytokines at 4-week follow-up
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Stimulation-associated perceptions
Time frame: From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
Therapy dropout rate
Time frame: From the beginning of iTBS treatment to the end of iTBS treatment
Serious Adverse Events (SAEs)
Time frame: From the beginning of iTBS treatment to the end of iTBS treatment
Self-reported depression: BDI-II
Time frame: From enrollment to the end of iTBS-treatment
Self-reported depression at 4-week follow-up: BDI-II
Time frame: From enrollment to 4 weeks after the end of iTBS-treatment
Self-rated gesture perception and production: BAG
Time frame: From enrollment to the end of iTBS-treatment
Self-rated gesture perception and production at 4-week follow-up: BAG
Time frame: From enrollment to 4 weeks after the end of iTBS-treatment
Epigenetic changes of neurotrophic and immunological factors
Time frame: From enrollment to the end of iTBS treatment
Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Concentrations of markers of neuronal damage
Time frame: From enrollment to the end of iTBS treatment
Concentrations of markers of neuronal damage at 4-week follow-up
Time frame: From enrollment to 4 weeks after the end of iTBS treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided. Whether IPD may be shared has not yet been decided. IPD might not be shared due to data protection laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasmus Schülke, MD (Dr. med.) principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta-burst stimulation in people with Schizophrenia Patients, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasmus Schülke, MD (Dr. med.) (+49 511 532 2039, schuelke.rasmus@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in negative symptoms (time frame: From enrollment to the end of iTBS treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.