NCT05100888Completed
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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 ERPs, 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 19 Oct 2021
- Start date
- 11 Jul 2022
- Primary completion date
- 24 Mar 2026
- Lead sponsor
- Semmelweis University
- Diseases
- Schizophrenia
- NCT number
- NCT05100888
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 11 Jul 2022 to the primary completion date, 24 Mar 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
- alcohol or drug abuse within the past 3 months, and
- Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device
Other illness
- any significant neurological illness;
- history of head injury with loss of consciousness for more than 1 hour
- history of epileptic seizures or epileptic activity on the baseline EEG (evaluated by an expert in clinical EEG and epilepsy),
- Severe heart failure
Other
- mental retardation
- depressive episode or antidepressant treatment in the past 4 weeks.
- Severe positive symptoms inferfere with cognitive tests
- Skin surface is severly injured in the stimulated region of the skull
- Sclerosis multiplex
- Pregnancy
- Severe sleep deprivation
- Increased intracranial pressure
- Untreated migrain
Who the study is looking for
- diagnosis of schizophrenia or schizoaffective disorder;
- clinically stabilized on antipsychotic: a stable dose of antipsychotic medication for \>4 weeks;
- age 18-60 years, and
- presence of negative symptoms (based on PANSS): a negative subscore ≥16 points and \[one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3\]
Age in the registry: 18 years to 60 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 |
|---|---|---|---|
| Department of Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.