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CompletedNCT05100888tbTMS_SCH21Updated Mar 30, 2026

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

An interventional study of repetitive Transcranial Magnetic Stimulation (rTMS) in Transcranial Magnetic Stimulation Repetitive and Schizophrenia, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Semmelweis University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Transcranial Magnetic Stimulation Repetitive
  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 76 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 18-60 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

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. Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device
  9. Skin surface is severly injured in the stimulated region of the skull
  10. Sclerosis multiplex
  11. Pregnancy
  12. Severe sleep deprivation
  13. Severe heart failure
  14. Increased intracranial pressure
  15. Untreated migrain
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Theta-burst rTMS

    Theta-burst repetitive transcranial magnetic stimulation

    Device: repetitive Transcranial Magnetic Stimulation (rTMS)

  • Sham comparator
    Sham stimulation

    Sham stimulation of the same location

    Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

  • Devicerepetitive Transcranial Magnetic Stimulation (rTMS)

    Theta-burst stimulation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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.

    Time frame: 4 weeks

  4. 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.

    Time frame: 4 weeks

  5. 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.

    Time frame: 4 weeks

  6. 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • Department of Psychiatry and Psychotherapy
    Budapest, Budapest 1083, Hungary
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05100888
Lead sponsor
Semmelweis University
Responsible party
Gábor Csukly (Assistant Professor, Semmelweis University) — Principal investigator
First posted
Oct 29, 2021
Start date
Jul 11, 2022
Primary completion
Mar 24, 2026
Completion
Mar 24, 2026
Last update
Mar 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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