This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia
This double-blind RCT aims to explore the efficacy of intensiveTranscranial Magnetic Stimulation (TMS) in schizophrenia spectrum disorders. Previous studies in various disorders suggest that intensive TMS is efficacious and safe. Participants will undergo neuronavigated intermittent theta burst TMS, targeted to individual network targets, at an accelerated protocol (multiple sessions a day), The primary goal is to determine the efficacy of this protocol in alleviating negative symptoms of schizophrenia. Additionally, the study will measure the impact of accelerated TMS on a range of clinical and cognitive outcomes, along with neuroimaging markers indicative of symptom response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Intermittent Theta Burst Stimulation (iTBS) pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses for up to 8 sessions daily for 5 days
Campus Biotech
Geneva, Switzerland
RECRUITINGIndrit Bègue
Geneva, Switzerland
NOT_YET_RECRUITINGBrief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12.
This outcome measure focuses on the evaluation of changes in apathy symptoms in participants, utilizing the apathy subscale of the Brief Negative Symptoms Scale (BNSS-Apathy). Apathy symptoms will be assessed at baseline (pre-intervention) and subsequently at follow-up visits scheduled at weeks 1, 6, and 12 post-intervention. The primary endpoint of this measure is the change in BNSS-Apathy scores from baseline to each follow-up point, aiming to capture the trajectory of symptom changes across the study period. The BNSS-Apathy subscale score, derived from specific item responses, provides a quantitative measure of apathy severity, allowing for statistical analysis of symptom changes over time. Higher scores reflect greater severity of symptoms. Maximum score of BNSS-Apathy subscale score is 42 (severe apathy), minimum score is 0.
Time frame: at 12 weeks
Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up
This outcome measure focuses on the evaluation of apathy and psychosis symptoms
Time frame: at 1 week
Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up
This outcome measure focuses on the evaluation of apathy and psychosis symptoms
Time frame: at 6 weeks
Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up
This outcome measure focuses on the evaluation of apathy and psychosis symptoms
Time frame: at 12 weeks
Self reported Negative Scale SNS scores and its sub-scales at follow-up
This outcome measure focuses on the self-reported evaluation of apathy
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Time frame: at 1 week
Self reported Negative Scale SNS scores and its sub-scales at follow-up
This outcome measure focuses on the self-reported evaluation of apathy
Time frame: at 6 weeks
Self reported Negative Scale SNS scores and its sub-scales at follow-up
This outcome measure focuses on the self-reported evaluation of apathy
Time frame: at 12 weeks
Brief neurocognitive assessment (BNA) scores at follow-up
This outcome measure focuses on the evaluation of cognitive function
Time frame: at 6 weeks
Auditory Hallucinations Rating Scale (AHRS) scores at follow-up
This outcome measure focuses on the evaluation of auditory hallucinations
Time frame: at 6 weeks
Calgary Depression Scale (CDSS) scores at follow-up
This outcome measure focuses on the evaluation of depression symptoms
Time frame: at 6 weeks
Young Mania Rating Scale (YMRS) scores at follow-up
This outcome measure focuses on the evaluation of mania symptoms
Time frame: at 6 weeks
Personal and social performance scale (PSP) scores at follow-up
This outcome measure focuses on the evaluation of psychosocial functioning
Time frame: at 12 weeks
Deep-phenotyping outcome - sEBR (spontaneous eye blink)
This outcome measure focuses on the evaluation of sEBR
Time frame: at 6 weeks
Deep-phenotyping outcome - facial expressions
This outcome measure focuses on the evaluation of facial expressions
Time frame: at 6 weeks
Deep-phenotyping outcome - accelerometer
This outcome measure focuses on the evaluation of accelerometry
Time frame: at 6 weeks
Cerebellar-cortical functional connectivity
This outcome measure focuses on cerebellar-cortical functional connectivity
Time frame: at 1 week
Cerebellar-cortical structural connectivity
This outcome measure focuses on cerebellar-cortical structural connectivity
Time frame: at 6 weeks
Cerebellar-cortical structural connectivity
This outcome measure focuses on cerebellar-cortical structural connectivity
Time frame: at 12 weeks