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Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Description

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.

Conditions

SchizophreniaSmoking CessationTobacco Use
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Related Conditions:

SchizophreniaSmoking CessationTobacco Use

Study Overview

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Study Details

Study overview

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.

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Stony Brook

Stony Brook University, Stony Brook, New York, United States, 11794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stony Brook University,

Study Record Dates

2028-08-31