Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
Schizophrenia, Smoking Cessation, Tobacco Use
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring PET, UCB-J, fMRI, Schizophrenia, Smoking Cessation, Tobacco Use
Eligibility Criteria
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 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* The FDA website currently states that the Brainsway device used in this study is contraindicated for patients who have "metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes." We will monitor the FDA guidelines and implement any changes to the inclusion/exclusion criteria based on their most updated recommendations.
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active deep transcranial magnetic stimulation (dTMS)
Sham
Each treatment consists of 60 trains, each lasting 3 sec and interleaved with a 15 sec delay. The entire treatment is delivered over 20 min. The treatment goes for 5 days/week and for a total of 3 weeks.
Active and sham cards do not differ in appearance, and both coils are enclosed within the same helmet, enabling double-blind administration. The same procedure will be done, the only difference is that the sham card does not deliver any stimulation.