Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms (tbTMS_SCH21)

Semmelweis University

Status: Active, not recruiting

Conditions: Transcranial Magnetic Stimulation Repetitive; Schizophrenia

Treatments: Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05100888

TB-rTMS_SCH2021

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Theta-burst rTMS

Experimental group

Description:

Theta-burst repetitive transcranial magnetic stimulation

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Sham stimulation

Sham Comparator group

Description:

Sham stimulation of the same location

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (rTMS)