Tests brain stimulation for low motivation in schizophrenia
Tests non-invasive cerebellar stimulation to reduce apathy in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: Brain Circuitry Therapeutics for Schizophrenia
Key facts
- Where
- Geneva, SwitzerlandSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06341517, who can take part
Where in Switzerland
- Campus BiotechGeneva, SwitzerlandTaking people
- Indrit BègueGeneva, SwitzerlandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Indrit Begue
- Trial code
- NCT06341517
- Record updated
- 19 November 2024
- Original description
This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophreniaRead full original descriptionShow less
Brain Circuitry Therapeutics for Schizophrenia - A Cross-species Longitudinal Randomized Controlled Clinical Study to Treat Negative Symptoms of Schizophrenia Using Non-invasive Stimulation of the Cerebellum
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
Inclusion: 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).
Exclusion: Metallic objects/implants (excluding dental fillings) unless cleared to be MRI compatible (i.e. MRI compatible joint replacement); Any implants controlled by physiological signs in/near the head; Pacemaker; Implanted medication pump; Vagal nerve stimulator; Deep brain stimulator or TENS unit; Ventriculo-peritoneal shunt; Cochlear implant; Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.); Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation; Previous enrolment into the current investigation; History of fainting spells of unknown or undetermined aetiology that might constitute seizures; History of multiple seizures or diagnosis of epilepsy; Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease; Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.); Intracranial lesion, from a known genetic disorder or from acquired neurologic disease (e.g. stroke, tumor, cerebral palsy, severe head injury, or significant dysmorphology); History of head injury resulting in prolonged loss of consciousness (>15minutes) or neurological sequelae; Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, intellectual retardation, dementia, etc. of the subject; Having legal obligation for psychiatric treatment; Impaired ability to sense heat/pain, open wounds etc; Increased intracranial pressure; Ongoing pregnancy and breastfeeding. All participants capable of becoming pregnant will be required to have active contraception; any participant who is pregnant or breastfeeding will not be enrolled in the study; Other exclusion criteria; Enrolment of the PI, his/her family members, employees and other dependent persons.