RecruitingNot ApplicableNCT06341517

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


Sponsor

Indrit Begue

Enrollment

70 participants

Start Date

Apr 15, 2024

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

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

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


Locations(2)

Campus Biotech

Geneva, Switzerland

Indrit Bègue

Geneva, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06341517


Related Trials