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Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms | Clinical Trials | Clareo Health

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

Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial

NCT05100888•Semmelweis University

View on ClinicalTrials.gov

Summary

The major target of the study is to confirm the safety and efficacy of our augmented protocol of theta-burst TMS in schizophrenia. Our aim is to confirm the beneficial effects of rTMS treatment on multiple aspects of the disorder such as (1) clinical aspect in terms of PANSS, (2) cognitive aspect such as emotion recognition (ER) and working memory (WM) / distractor filtering (DF) performance, and (3) neurobiology in terms of electrophysiology correlates of ER, WM and DF such as event related theta synchronization, resting state theta power, and network connectivity. Response prediction to (theta-burst) TB-rTMS will be the exploratory part of the study.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (1)

Department of Psychiatry and Psychotherapy

Budapest, Budapest, Hungary

Key Dates

Start Date

July 11, 2022

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

January 6, 2026

Enrollment

ESTIMATED participants

Conditions

Transcranial Magnetic Stimulation RepetitiveSchizophrenia

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS)

DEVICE

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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