Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms

Launched by SEMMELWEIS UNIVERSITY · Oct 20, 2021

Keywords

ClinConnect Summary

This study is testing whether a brain-stimulation treatment called theta-burst repetitive transcranial magnetic stimulation (rTMS) can help people with schizophrenia who have prominent negative symptoms (like low motivation, reduced social interaction, and flat mood) and certain thinking problems. Participants will be randomly assigned to receive either real rTMS or sham (fake) stimulation in a double-blind setup, meaning neither the participants nor the researchers know which treatment is being given. The main goal is to see if the real treatment reduces negative symptoms after about 4 weeks, using a standard symptom scale. Researchers will also look at several cognitive tests (memory, thinking flexibility, emotion recognition, and social understanding) and safety.

To join, adults aged roughly 18 to 55 with schizophrenia or schizoaffective disorder must be on a stable antipsychotic medication for at least 4 weeks and have meaningful negative symptoms. Exclusions include significant neurological problems, a history of seizures or severe head injury, recent substance abuse, pregnancy, implanted devices that could be affected by magnetic stimulation, and several other health or safety concerns. The study is being run at the Department of Psychiatry and Psychotherapy, Semmelweis University in Budapest, Hungary, and aims to enroll about 90 participants. As of now, recruitment is ongoing by invitation, with results expected after the 4-week assessment and study completion anticipated in late 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. diagnosis of schizophrenia or schizoaffective disorder;
• • 2. clinically stabilized on antipsychotic: a stable dose of antipsychotic medication for \>4 weeks;
• • 3. age 18-55 years, and
• • 4. presence of negative symptoms (based on PANSS): a negative subscore ≥16 points and \[one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3\]
• Exclusion Criteria:
• • 1. any significant neurological illness;
• • 2. mental retardation
• • 3. history of head injury with loss of consciousness for more than 1 hour
• • 4. history of epileptic seizures or epileptic activity on the baseline EEG (evaluated by an expert in clinical EEG and epilepsy),
• • 5. alcohol or drug abuse within the past 3 months, and
• • 6. depressive episode or antidepressant treatment in the past 4 weeks.
• • 7. Severe positive symptoms inferfere with cognitive tests
• • 8. ECT in the medical history
• • 9. Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device
• • 10. Skin surface is severly injured in the stimulated region of the skull
• • 11. Sclerosis multiplex
• • 12. Pregnancy
• • 13. Severe sleep deprivation
• • 14. Severe heart failure
• • 15. Increased intracranial pressure
• • 16. Untreated migrain