Transcranial magnetic stimulation to improve motivation in schizophrenia

Switzerland (ICTRP)

ICTRP Trial ID
NCT06341517 (ICTRP)

Official title (approved by ethics committee)
Brain Circuitry Therapeutics for Schizophrenia (BASEC)

Academic title
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 (ICTRP)

Public title
Brain Circuitry Therapeutics for Schizophrenia (ICTRP)

Disease under investigation
Schizophrenia; Psychosis (ICTRP)

Intervention under investigation
Device: iTBS (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Inclusion/Exclusion criteria
Gender: All
Maximum age: 65 Years
Minimum age: 18 Years
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. (ICTRP)

not available

Primary and secondary end points
Brief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12. (ICTRP)

Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up;Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up;Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up;Self reported Negative Scale SNS scores and its sub-scales at follow-up;Self reported Negative Scale SNS scores and its sub-scales at follow-up;Self reported Negative Scale SNS scores and its sub-scales at follow-up;Brief neurocognitive assessment (BNA) scores at follow-up;Auditory Hallucinations Rating Scale (AHRS) scores at follow-up;Calgary Depression Scale (CDSS) scores at follow-up;Young Mania Rating Scale (YMRS) scores at follow-up;Personal and social performance scale (PSP) scores at follow-up;Deep-phenotyping outcome - sEBR (spontaneous eye blink);Deep-phenotyping outcome - facial expressions;Deep-phenotyping outcome - accelerometer;Cerebellar-cortical functional connectivity;Cerebellar-cortical structural connectivity;Cerebellar-cortical structural connectivity (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
University of Geneva, Switzerland (ICTRP)

Additional contacts
Indrit B?gue, MD, PhD, indrit.begue@unige.ch, +41589440300 (ICTRP)

Secondary trial IDs
BASEC-ID:2023-D0117 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06341517 (ICTRP)