Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms
tbTMS_SCH21
1 other identifier
interventional
76
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2026
CompletedMarch 30, 2026
March 1, 2026
3.7 years
October 19, 2021
March 25, 2026
Conditions
Outcome Measures
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.
4 weeks
Secondary Outcomes (6)
Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests
4 weeks
Cognitive functioning/Executive functioning - Wisconsin Card Sorting test
4 weeks
Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '
4 weeks
Social cognition 2 - The 'Faux Pas' test.
4 weeks
Facial Emotion Recogniton - Karolinska Directed Emotional Face set
4 weeks
- +1 more secondary outcomes
Study Arms (2)
Theta-burst rTMS
EXPERIMENTALTheta-burst repetitive transcranial magnetic stimulation
Sham stimulation
SHAM COMPARATORSham stimulation of the same location
Interventions
Theta-burst stimulation
Eligibility Criteria
You may qualify if:
- 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 \[one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3\]
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Psychotherapy
Budapest, Budapest, 1083, Hungary
Related Publications (1)
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.
PMID: 38632647DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 19, 2021
First Posted
October 29, 2021
Study Start
July 11, 2022
Primary Completion
March 24, 2026
Study Completion
March 24, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03