NCT05724810

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Smoking Cessation
• Tobacco Use

Interventions

Type	Name	Description
DEVICE	Active deep transcranial magnetic stimulation (dTMS)	First, the investigators will find the position of the right abductor pollicis brevis (APB) motor cortex, finding the minimal motor threshold (MT) required for its activation, which determines the strength of the pulses. After determining the MT, dTMS stimulation is applied 6 cm anterior to the motor "hot spot", at 120% of the MT. The target threshold is built toward gradually. During the first treatment, participants receive stimulation at 100% of the MT. During the second treatment, stimulation intensity increases to 110% of the MT. Beginning at the third treatment and continuing onward, participants receive treatment at 120% of the MT for the course of the treatment.
DEVICE	Sham dTMS	Sham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation.

Timeline

• Start date: 2023-04-04
• Primary completion: 2027-08-31
• Completion: 2028-08-31
• First posted: 2023-02-13
• Last updated: 2024-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study