NCT05724810

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

April 22, 2026

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

January 27, 2023

Last Update Submit

April 17, 2026

Conditions

SchizophreniaSmoking CessationTobacco Use

Keywords

PETUCB-JfMRISchizophreniaSmoking CessationTobacco Use

Outcome Measures

Primary Outcomes (3)

  • Insula synaptic density

    PET with UCB-J will be used to look at synaptic density pre/post intervention

    Change from Baseline at 3 weeks

  • Smoking self-administration

    Laboratory tobacco self-administration will be examined pre/post the intervention as a measure of smoking vigor

    Change from Baseline at 3 weeks

  • Insula-centric functional connectivity

    fMRI will be used to look at insula circuit functional connectivity pre/post intervention

    Change from Baseline at 3 weeks

Secondary Outcomes (3)

  • Symptoms of Psychosis

    up to 4 times over 3 weeks

  • Nicotine Craving

    post dTMS over 3 weeks

  • Cigarettes per Day

    Change from Baseline at 3 weeks

Study Arms (2)

Active deep transcranial magnetic stimulation (dTMS)

EXPERIMENTAL

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.

Device: Active deep transcranial magnetic stimulation (dTMS)

Sham

SHAM COMPARATOR

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.

Device: Sham dTMS

Interventions

Sham dTMSDEVICE

Sham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation.

Sham
Active deep transcranial magnetic stimulation (dTMS)DEVICE

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.

Also known as: repetitive transcranial magnetic stimulation (rTMS)
Active deep transcranial magnetic stimulation (dTMS)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Clinically significant psychopathology other than schizophrenia, schizophreniform, schizoaffective disorder, or psychotic disorder NOS
  • Current or past substance use disorder, except TUD
  • Current use of smoking cessation medications/products
  • Change in schizophrenia medication within 4 weeks
  • Hospitalization in the last 3 months
  • History of suicidal or homicidal tendencies
  • 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)
  • Pregnancy or lactation (females)
  • Lack of effective birth control (females)
  • Contraindications to MRI or PET
  • Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
  • Prisoners
  • Contraindications to dTMS\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • 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.

    PMID: 35217662BACKGROUND

MeSH Terms

Conditions

SchizophreniaSmoking CessationTobacco Use

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Active and sham cards do not differ in appearance, and both coils are enclosed within the same helmet, enabling double-blind administration.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After enrollment, participants will be randomized between-subjects to active dTMS or sham.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor and Chair of Psychiatry

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 13, 2023

Study Start

April 4, 2023

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

April 22, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)