Transcranial Magnetic Stimulation RepetitivetbTMS_SCH21NCT05100888
Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Transcranial Magnetic Stimulation Repetitive and Schizophrenia, run by Semmelweis University at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transcranial Magnetic Stimulation Repetitive, Schizophrenia
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteHungary
- Study dates
- 11 Jul 2022to 24 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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]
Who cannot join
- any significant neurological illness;
- mental retardation
- 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),
- alcohol or drug abuse within the past 3 months, and
- depressive episode or antidepressant treatment in the past 4 weeks.
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- Severe positive symptoms inferfere with cognitive tests
- Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device
- Skin surface is severly injured in the stimulated region of the skull
- Sclerosis multiplex
- Pregnancy
- Severe sleep deprivation
- Severe heart failure
- Increased intracranial pressure
- Untreated migrain
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Psychiatry and Psychotherapy
Budapest, Budapest, 1083
About this study
Official title: Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial
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.
Read the detailed description
Response prediction will be based on spectral slope, individual alpha peak, and frontal alpha asymmetry, calculated from baseline resting-state EEG in the closed-eye condition (the open-eye condition may also be used). Baseline resting-state fMRI will also be used to predict responses.
- Being tested
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation (rTMS)Device
Theta-burst stimulation
| Study group | Role | What they receive |
|---|---|---|
| Theta-burst rTMS | Experimental | Theta-burst repetitive transcranial magnetic stimulation Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham stimulation | Sham comparator | Sham stimulation of the same location Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale, Negative subscore
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. It is the gold standard in the treatment monitoring of schizophrenia.The scale has three subscales : positive, negatve and general symptom score. We use the negative subscore as primary outcome. Its minimum and maximum scores are 7 and 49 respectively. Higher values indicate worse outcome.
Measured: 4 weeks
Secondary outcomes (6)
Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests
They will be used to assess working memory. Digits Recalled is the primary outcome measure ranging between 2 and 10. Lower values indicate worse outcome.
Measured: 4 weeks
Cognitive functioning/Executive functioning - Wisconsin Card Sorting test
The test will be used to measure cognitive flexibility/Executive functioning. Number of persevarative errors is the major outcome variable of the test, its minimum is 0, while it has no theroretical maximum value. Higher values indicate worse outcome. Punishment sensitivity (P) from the reinforcement learning model of WCST will also be used as outcome variable. Its minimum value is 0 and it has no theoretical maximum value. Lower values indicate worse outcome.
Measured: 4 weeks
Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '
The total score is the primary outcome, which ranges between 0 and 37 points. Lower values indicate worse outcome.
Measured: 4 weeks
Social cognition 2 - The 'Faux Pas' test.
Measures Theory of Mind (ToM), and the primary outcome measure is the total score, which ranges between 0 and 1. Lower values indicate worse outcome.
Measured: 4 weeks
Facial Emotion Recogniton - Karolinska Directed Emotional Face set
Facial expression recognition task. Subject have to identify emotional expressions from photographs of 8 male and 8 female subjects. The pictures are chosen from Karolinska Directed Emotional Face set. There are 3 photographs from each faces (happy, neutral, and sad). Hit rate is the primary outcome measure, which ranges from 0% to 100%, and lower values indicate worse outcome. A 64-channel high-density EEG is recorded during the task, and ERPs (e.g., n170) are calculated for each emotion condition and EEG channel.
Measured: 4 weeks
Safety in terms of adverse events
Safety in terms of the number of serious adverse events (SAE).
A Serious Adverse Event is any untoward medical occurrence that:
- Results in death
- Is life-threatening or
- Requires in-patient confinement or prolongation of existing confinement or
- Results in persistent or significant disability/incapacity or
- Is a congenital anomaly/birth defect.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start11 Jul 2022
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic Stimulation RepetitiveStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gábor Csukly, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100888
- Sponsor's protocol ID
- TB-rTMS_SCH2021
- Acronym
- tbTMS_SCH21
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Csukly G, Orban-Szigeti B, Suri K, Zsigmond R, Herman L, Simon V, Kabaji A, Bata B, Harsfalvi P, Vass E, Csibri E, Farkas K, Rethelyi J. Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial. Trials. 2024 Apr 17;25(1):269. doi: 10.1186/s13063-024-08106-9.
PubMed 38632647
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05100888
- Acronym / sponsor ID
- tbTMS_SCH21 / TB-rTMS_SCH2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Response prediction will be based on spectral slope, individual alpha peak, and frontal alpha asymmetry, calculated from baseline resting-state EEG in the closed-eye condition (the open-eye condition may also be used). Baseline resting-state fMRI will also be used to predict responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theta-burst rTMS | Experimental | Device: repetitive Transcranial Magnetic Stimulation (rTMS)Theta-burst repetitive transcranial magnetic stimulation |
| Sham stimulation | Sham comparator | Device: repetitive Transcranial Magnetic Stimulation (rTMS)Sham stimulation of the same location |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (15 listed)
- any significant neurological illness;
- mental retardation
- 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),
- alcohol or drug abuse within the past 3 months, and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS)Theta-burst stimulation | Device | Sham stimulation, Theta-burst rTMS |
Primary outcome
Positive and Negative Syndrome Scale, Negative subscore
Time frame: 4 weeks
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. It is the gold standard in the treatment monitoring of schizophrenia.The scale has three subscales : positive, negatve and general symptom score. We use the negative subscore as primary outcome. Its minimum and maximum scores are 7 and 49 respectively. Higher values indicate worse outcome.
6 secondary outcomes
Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests
Time frame: 4 weeks
Cognitive functioning/Executive functioning - Wisconsin Card Sorting test
Time frame: 4 weeks
Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '
Time frame: 4 weeks
Social cognition 2 - The 'Faux Pas' test.
Time frame: 4 weeks
Facial Emotion Recogniton - Karolinska Directed Emotional Face set
Time frame: 4 weeks
Safety in terms of adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 38632647Csukly G, Orban-Szigeti B, Suri K, Zsigmond R, Herman L, Simon V, Kabaji A, Bata B, Harsfalvi P, Vass E, Csibri E, Farkas K, Rethelyi J. Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial. Trials. 2024 Apr 17;25(1):269. doi: 10.1186/s13063-024-08106-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Transcranial Magnetic Stimulation Repetitive and Schizophrenia, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale, Negative subscore (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.