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

NCT ID: NCT05100888

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2026-04-01

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 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.

Conditions

Transcranial Magnetic Stimulation Repetitive; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Theta-burst rTMS

Theta-burst repetitive transcranial magnetic stimulation

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

Theta-burst stimulation

Sham stimulation

Sham stimulation of the same location

Group Type: SHAM_COMPARATOR

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

Theta-burst stimulation

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS)

Theta-burst stimulation

Intervention Type: DEVICE

Eligibility Criteria

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 18-55 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

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. ECT in the medical history

9. Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device

10. Skin surface is severly injured in the stimulated region of the skull

11. Sclerosis multiplex

12. Pregnancy

13. Severe sleep deprivation

14. Severe heart failure

15. Increased intracranial pressure

16. Untreated migrain

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Gábor Csukly

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Psychiatry and Psychotherapy

Budapest, Budapest, Hungary

Countries

Hungary

References

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.

Reference Type: DERIVED

PMID: 38632647 (View on PubMed)

Other Identifiers

TB-rTMS_SCH2021

Identifier Type: -

Identifier Source: org_study_id