Brain Circuitry Therapeutics for Schizophrenia
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
Indrit Begue
70 participants
Apr 15, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria28
- 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)
- 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.)
- 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
- Impaired ability to sense heat/pain, open wounds etc.
- Increased intracranial pressure
- 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
- 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.
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)
- 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.
- 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
- Enrolment of the PI, his/her family members, employees and other dependent persons.
Interventions
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
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06341517