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Completed

NCT Number: NCT05100888

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

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.

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Key information

Conditions

Transcranial Magnetic Stimulation Repetitive Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy

Budapest, 1083, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

Theta-burst stimulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests

    Time frame: 4 weeks

    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.

  2. Cognitive functioning/Executive functioning - Wisconsin Card Sorting test

    Time frame: 4 weeks

    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.

  3. Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '

    Time frame: 4 weeks

    The total score is the primary outcome, which ranges between 0 and 37 points. Lower values indicate worse outcome.

  4. Social cognition 2 - The 'Faux Pas' test.

    Time frame: 4 weeks

    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.

  5. Facial Emotion Recogniton - Karolinska Directed Emotional Face set

    Time frame: 4 weeks

    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.

  6. Safety in terms of adverse events

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Acronym: tbTMS_SCH21

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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