Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-04-15
2027-12-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
Active intermittent theta burst stimulation (iTBS) to the cerebellum at 80% of active motor threshold.
iTBS
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
Placebo
Sham intermittent theta burst stimulation (iTBS) to the cerebellum
iTBS
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
Interventions
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iTBS
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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Geneva, Switzerland
OTHER
Indrit Begue
OTHER
Responsible Party
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Indrit Begue
Assistant Professor
Locations
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Campus Biotech
Geneva, , Switzerland
Indrit Bègue
Geneva, , Switzerland
Countries
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Facility Contacts
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Other Identifiers
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BASEC-ID:2023-D0117
Identifier Type: -
Identifier Source: org_study_id
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