Clinical trial NCT05100888: Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms
Official title: Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Transcranial Magnetic Stimulation Repetitive
Schizophrenia
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Positive and Negative Syndrome Scale, Negative subscore
timeFrame: 4 weeks
Secondary outcomes:
measure: Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests
timeFrame: 4 weeks
measure: Cognitive functioning/Executive functioning - Wisconsin Card Sorting test
timeFrame: 4 weeks
measure: Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '
timeFrame: 4 weeks
measure: Social cognition 2 - The 'Faux Pas' test.
timeFrame: 4 weeks
measure: Facial Emotion Recogniton - Karolinska Directed Emotional Face set
timeFrame: 4 weeks
measure: Safety in terms of adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Psychiatry and Psychotherapy
Study officials:
References: