Non-invasive brain stimulation for improving apathy in 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
This study is testing if a special type of brain stimulation can help reduce feelings of apathy in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 2 sites (Geneva and 1 other locations) |
| Trial ID | NCT06341517 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intensive Transcranial Magnetic Stimulation (TMS) in patients with schizophrenia spectrum disorders. It employs a double-blind randomized design, where participants will receive neuronavigated intermittent theta burst TMS targeted at specific brain networks. The study aims to assess the impact of this accelerated TMS protocol on alleviating negative symptoms, particularly apathy, while also measuring various clinical, cognitive, and neuroimaging outcomes. The goal is to determine if this innovative approach can lead to significant improvements in patients' conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a stable diagnosis of schizophrenia spectrum disorders who have not been hospitalized in the last three months.
Not a fit: Patients with active psychotic symptoms or a current major depressive episode may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce apathy and improve overall functioning in patients with schizophrenia.
How similar studies have performed: Previous studies have shown that intensive TMS can be effective in treating various disorders, suggesting potential success for this novel application in schizophrenia.
Eligibility criteria
Show full inclusion / exclusion criteria
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) Exclusion criteria related to MRI or TMS * 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. Other exclusion criteria * 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.
Where this trial is running
Geneva and 1 other locations
- Campus Biotech — Geneva, Switzerland (Recruiting)
- Indrit Bègue — Geneva, Switzerland (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.