Non-invasive brain stimulation for improving apathy in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Campus Biotech
  Geneva, Switzerland Recruiting
• Indrit Bègue
  Geneva, Switzerland Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.