Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia (NCT05724810) | Clinical Trial Compass
TerminatedNot Applicable
Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
Stopped: Funding was not renewed.
United States13 participantsStarted 2023-04-04
Plain-language summary
Purpose of the study: Evaluate the effect of deep repetitive transcranial magnetic stimulation (deep rTMS; hereafter abbreviated as "dTMS") on synaptic density measured with positron emission tomography (PET) and the radiotracer \[11C\]UCB-J. The investigators also seek to link plasticity changes in the regions targeted by the electric field (especially, the insula) to changes in the functioning of insula circuits and behavioral cigarette usage in patients with schizophrenia (SCZ).
Importance of the study: This is the first study designed to directly evaluate the mechanism of action (MOA) of dTMS for smoking disruption in patients with SCZ. Patients with SCZ are a vulnerable population in high, immediate need of new smoking therapeutics for reducing premature morbidity and mortality.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Ages 18-60
✓. DSM-5 criteria for schizophreniform, schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS).
✓. DSM-5 diagnosis of nicotine use disorder with current daily smoking, and a desire to cut down or quit.
✓. Negative urine toxicology (other than cannabis) maintained throughout study participation
✓. Fluent English Speaker
✓. Capacity for informed consent
Exclusion criteria
✕. Clinically significant psychopathology other than schizophrenia, schizophreniform, schizoaffective disorder, or psychotic disorder NOS
✕. Current or past substance use disorder, except TUD
✕. Current use of smoking cessation medications/products
✕. Change in schizophrenia medication within 4 weeks
✕. History of epilepsy, stroke, cerebral aneurysm, significant head injury resulting in \>10 min loss of consciousness, movement disorder, clinically significant electrolyte abnormalities, or use of clozapine (seizure risks)