RECRUITING

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Quick Facts

Study Start:2023-04-04
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05724810

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 18-60
  2. 2. DSM-5 criteria for schizophreniform, schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS).
  3. 3. DSM-5 diagnosis of nicotine use disorder with current daily smoking, and a desire to cut down or quit.
  4. 4. Negative urine toxicology (other than cannabis) maintained throughout study participation
  5. 5. Fluent English Speaker
  6. 6. Capacity for informed consent
  1. 1. Clinically significant psychopathology other than schizophrenia, schizophreniform, schizoaffective disorder, or psychotic disorder NOS
  2. 2. Current or past substance use disorder, except TUD
  3. 3. Current use of smoking cessation medications/products
  4. 4. Change in schizophrenia medication within 4 weeks
  5. 5. Hospitalization in the last 3 months
  6. 6. History of suicidal or homicidal tendencies
  7. 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. 8. Pregnancy or lactation (females)
  9. 9. Lack of effective birth control (females)
  10. 10. Contraindications to MRI or PET
  11. 11. Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
  12. 12. Prisoners
  13. 13. Contraindications to dTMS\*
  14. * 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.

Contacts and Locations

Study Contact

Anissa Abi-Dargham, MD
CONTACT
631-638-1575
anissa.abi-dargham@stonybrookmedicine.edu
Scott J Moeller, PhD
CONTACT
631-638-3223
scott.moeller@stonybrookmedicine.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Stony Brook University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • PET
  • UCB-J
  • fMRI
  • Schizophrenia
  • Smoking Cessation
  • Tobacco Use

Additional Relevant MeSH Terms

  • Schizophrenia
  • Smoking Cessation
  • Tobacco Use