Schizophrenia; Psychosis
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEiTBS
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
Sponsors
University of Geneva, Switzerland
Indrit Begue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria * Capable of giving informed consent as evaluated by the treating psychiatrist * Informed Consent signed by the subject * Patients aged 18 - 65 years diagnosed with a schizophrenia spectrum disorder (including schizophrenia, schizoaffective or non-organic psychosis, psychotic disorder NOS) according to DSM-5 criteria * Clinically stable condition judged by their treating psychiatrist * Background antipsychotic medication treatments have remained unchanged for at least 4 weeks * No hospitalization in acute psychiatry ward at least 3 months prior to study entry Specific
Exclusion criteria
related to psychopathology * Comorbid and clinically active current major depressive episode determined by the treating psychiatrist. * Active psychotic symptoms. In particular, patients that at Baseline have a PANSS scores of more than 4 in any of the following PANSS items: delusions, suspiciousness/persecution and hallucinatory behaviour will be considered not stable enough to participate. * Significant extrapyramidal side-effects quantified by total score of mSAS \> 12. * Increased sedation due to use of medication (slowing, drowsiness, slurred speech etc.) * Active daily use of substances (i.e. cocaine), including for therapeutically medical purposes (e.g., methadone substitution)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief 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. | at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebellar-cortical structural connectivity | at 6 weeks | This outcome measure focuses on cerebellar-cortical structural connectivity |
| Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up | at 1 week | This outcome measure focuses on the evaluation of apathy and psychosis symptoms |
| Self reported Negative Scale SNS scores and its sub-scales at follow-up | at 1 week | This outcome measure focuses on the self-reported evaluation of apathy |
| Brief neurocognitive assessment (BNA) scores at follow-up | at 6 weeks | This outcome measure focuses on the evaluation of cognitive function |
| Auditory Hallucinations Rating Scale (AHRS) scores at follow-up | at 6 weeks | This outcome measure focuses on the evaluation of auditory hallucinations |
| Cerebellar-cortical functional connectivity | at 1 week | This outcome measure focuses on cerebellar-cortical functional connectivity |
| Young Mania Rating Scale (YMRS) scores at follow-up | at 6 weeks | This outcome measure focuses on the evaluation of mania symptoms |
| Personal and social performance scale (PSP) scores at follow-up | at 12 weeks | This outcome measure focuses on the evaluation of psychosocial functioning |
| Deep-phenotyping outcome - sEBR (spontaneous eye blink) | at 6 weeks | This outcome measure focuses on the evaluation of sEBR |
| Deep-phenotyping outcome - facial expressions | at 6 weeks | This outcome measure focuses on the evaluation of facial expressions |
| Deep-phenotyping outcome - accelerometer | at 6 weeks | This outcome measure focuses on the evaluation of accelerometry |
| Calgary Depression Scale (CDSS) scores at follow-up | at 6 weeks | This outcome measure focuses on the evaluation of depression symptoms |
Countries
Switzerland
Outcome results
None listed