Using intermittent theta-burst stimulation to improve symptoms in schizophrenia
Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
This study is testing if a new brain stimulation technique can help reduce negative symptoms and improve thinking skills in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 1 site (Hanover, Lower Saxony) |
| Trial ID | NCT06740747 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intermittent theta-burst stimulation (iTBS) on negative symptoms and cognitive deficits in patients with schizophrenia. The study is randomized, sham-controlled, and double-blind, focusing on stimulating the cerebellar vermis and the left dorsolateral prefrontal cortex in a series of 10 sessions over two weeks. Researchers aim to determine if iTBS can significantly improve negative symptoms compared to sham stimulation, with assessments conducted before, immediately after, and four weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 diagnosed with schizophrenia who can provide informed consent.
Not a fit: Patients with electronic implants, severe physical illnesses, or those currently abusing drugs or alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to significant improvements in the quality of life for patients suffering from schizophrenia by alleviating negative symptoms and enhancing cognitive function.
How similar studies have performed: While the approach of using iTBS is relatively novel, preliminary studies have shown promise in similar applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanover, Lower Saxony
- Hannover Medical School — Hanover, Lower Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: Rasmus Schülke, MD (Dr. med.) — Hannover Medical School
- Study coordinator: Rasmus Schülke, MD (Dr. med.)
- Email: schuelke.rasmus@mh-hannover.de
- Phone: +49 511 532 2039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.