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Device

dTMS for Smoking Cessation in Schizophrenia

N/A
Recruiting
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 times over 3 weeks

Summary

This trial will study how dTMS affects brain chemistry in people with schizophrenia, and how this might help reduce smoking in this vulnerable population. #schizophrenia #smoking #dTMS #PET #brainchemistry

Who is the study for?
This trial is for English-speaking adults aged 18-60 with schizophrenia or related conditions who smoke daily and want to reduce or quit. They must be able to consent, have a negative drug test (except for cannabis), and meet DSM-5 criteria for nicotine use disorder.
What is being tested?
The study tests if deep transcranial magnetic stimulation (dTMS) affects synaptic density in the brain's insula region, measured by PET scans, and if it influences smoking behavior in schizophrenia patients.
What are the potential side effects?
Possible side effects of dTMS may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), hearing loss if ear protection isn't used during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 times over 3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 times over 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insula synaptic density
Insula-centric functional connectivity
Smoking self-administration
Secondary study objectives
Cigarettes per Day
Nicotine Craving
Symptoms of Psychosis

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active deep transcranial magnetic stimulation (dTMS)Experimental Treatment1 Intervention
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.
Group II: ShamPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
223 Previous Clinical Trials
41,514 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,897 Total Patients Enrolled
52 Trials studying Schizophrenia
5,394 Patients Enrolled for Schizophrenia

Media Library

Active deep transcranial magnetic stimulation (dTMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05724810 — N/A
Schizophrenia Research Study Groups: Active deep transcranial magnetic stimulation (dTMS), Sham
Schizophrenia Clinical Trial 2023: Active deep transcranial magnetic stimulation (dTMS) Highlights & Side Effects. Trial Name: NCT05724810 — N/A
Active deep transcranial magnetic stimulation (dTMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724810 — N/A
~23 spots leftby Aug 2027