Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
NCT ID: NCT05724810
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
38 participants
INTERVENTIONAL
2023-04-04
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
Sham dTMS
Sham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation.
Interventions
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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.
Sham dTMS
Sham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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\*
18 Years
60 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Stony Brook University
OTHER
Responsible Party
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Anissa Abi-Dargham
Distinguished Professor and Chair of Psychiatry
Locations
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Stony Brook University
Stony Brook, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Moeller SJ, Gil R, Weinstein JJ, Baumvoll T, Wengler K, Fallon N, Van Snellenberg JX, Abeykoon S, Perlman G, Williams J, Manu L, Slifstein M, Cassidy CM, Martinez DM, Abi-Dargham A. Deep rTMS of the insula and prefrontal cortex in smokers with schizophrenia: Proof-of-concept study. Schizophrenia (Heidelb). 2022 Feb 25;8(1):6. doi: 10.1038/s41537-022-00224-0.
Other Identifiers
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