Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Launched by STONY BROOK UNIVERSITY · Jan 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called deep repetitive transcranial magnetic stimulation (dTMS) to see if it can help reduce smoking in individuals with schizophrenia. The researchers want to understand how this treatment affects brain connections, particularly in a region called the insula, and how these changes might influence smoking behavior. This is important because people with schizophrenia often struggle with smoking, and finding effective ways to help them quit could improve their overall health and quality of life.

To join the study, participants need to be between 18 and 60 years old and have a diagnosis of schizophrenia or a related condition, along with a nicotine use disorder (meaning they currently smoke and want to quit or cut down). Participants should also be fluent in English and able to give their consent to join the study. Those who qualify will receive the dTMS treatment and have their progress monitored. It’s important to note that there are certain medical conditions and situations, such as pregnancy or recent hospitalizations, that would prevent someone from participating. This trial is currently recruiting, and it offers a unique opportunity to explore new ways to help a vulnerable group of people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 18-60
• • 2. DSM-5 criteria for schizophreniform, schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS).
• • 3. DSM-5 diagnosis of nicotine use disorder with current daily smoking, and a desire to cut down or quit.
• • 4. Negative urine toxicology (other than cannabis) maintained throughout study participation
• • 5. Fluent English Speaker
• • 6. Capacity for informed consent
• Exclusion Criteria:
• • 1. Clinically significant psychopathology other than schizophrenia, schizophreniform, schizoaffective disorder, or psychotic disorder NOS
• • 2. Current or past substance use disorder, except TUD
• • 3. Current use of smoking cessation medications/products
• • 4. Change in schizophrenia medication within 4 weeks
• • 5. Hospitalization in the last 3 months
• • 6. History of suicidal or homicidal tendencies
• • 7. 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)
• • 8. Pregnancy or lactation (females)
• • 9. Lack of effective birth control (females)
• • 10. Contraindications to MRI or PET
• • 11. Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
• • 12. Prisoners
• • 13. 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." The investigators will monitor the FDA guidelines and implement any changes to the inclusion/exclusion criteria based on their most updated recommendations.