Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
Stony Brook University
38 participants
Apr 4, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria13
- 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
- Hospitalization in the last 3 months
- History of suicidal or homicidal tendencies
- 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)
- Pregnancy or lactation (females)
- Lack of effective birth control (females)
- Contraindications to MRI or PET
- Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
- Prisoners
- Contraindications to dTMS\*
Interventions
First, the investigators will find the position of the right abductor pollicis brevis (APB) motor cortex, finding the minimal motor threshold (MT) required for its activation, which determines the strength of the pulses. After determining the MT, dTMS stimulation is applied 6 cm anterior to the motor "hot spot", at 120% of the MT. The target threshold is built toward gradually. During the first treatment, participants receive stimulation at 100% of the MT. During the second treatment, stimulation intensity increases to 110% of the MT. Beginning at the third treatment and continuing onward, participants receive treatment at 120% of the MT for the course of the treatment.
Sham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05724810