Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Stony Brook University
RECRUITING
Stony Brook
Contact Information
Primary
Anissa Abi-Dargham, MD
anissa.abi-dargham@stonybrookmedicine.edu
631-638-1575
Backup
Scott J Moeller, PhD
scott.moeller@stonybrookmedicine.edu
631-638-3223
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 38
Treatments
Experimental: Active deep transcranial magnetic stimulation (dTMS)
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.
Sham_comparator: Sham
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Stony Brook University

This content was sourced from clinicaltrials.gov