NCT06740747Recruiting
Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia
Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Dec 2024
- Start date
- 8 Apr 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Hannover Medical School
- Diseases
- Schizophrenia
- NCT number
- NCT06740747
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 8 Apr 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Current drug, medication, or alcohol abuse
- Planned changes in psychopharmacological medication within the next 2 weeks
Other illness
- 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
- Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden
Other
- Claustrophobia
- Pregnancy
- Simultaneous participation in another clinical trial
Who the study is looking for
- Diagnosis of schizophrenia (ICD-10: F20.-)
- Age: 18-65 years
- Ability to give informed consent
- Signed informed consent form
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.