Brain Circuitry Therapeutics for Schizophrenia (ATHENA)

Indrit Begue

Status

Enrolling

Conditions

Schizophrenia; Psychosis

Treatments

Device: iTBS

Study type

Interventional

Funder types

Other

Identifiers

NCT06341517

BASEC-ID:2023-D0117

Details and patient eligibility

About

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

Full description

This double-blind RCT aims to explore the efficacy of intensiveTranscranial Magnetic Stimulation (TMS) in schizophrenia spectrum disorders. Previous studies in various disorders suggest that intensive TMS is efficacious and safe.

Participants will undergo neuronavigated intermittent theta burst TMS, targeted to individual network targets, at an accelerated protocol (multiple sessions a day), The primary goal is to determine the efficacy of this protocol in alleviating negative symptoms of schizophrenia.

Additionally, the study will measure the impact of accelerated TMS on a range of clinical and cognitive outcomes, along with neuroimaging markers indicative of symptom response.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and 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.