SchizophreniaNCT05724810
Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
A study testing Active deep transcranial magnetic stimulation (dTMS) in people with Schizophrenia and Smoking Cessation, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Smoking Cessation, Tobacco Use
- What is being tested?
- Active deep transcranial magnetic stimulation (dTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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*
- The FDA website currently states that the Brainsway device used in this study is contraindicated for patients who have "metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes." The investigators will monitor the FDA guidelines and implement any changes to the inclusion/exclusion criteria based on their most updated recommendations.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Active deep transcranial magnetic stimulation (dTMS), Sham dTMS
- Keywords
- PET, UCB-J, fMRI, Schizophrenia, Smoking Cessation, Tobacco Use
- Medical subject headings
- Schizophrenia, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active deep transcranial magnetic stimulation (dTMS)Device
Also called repetitive transcranial magnetic stimulation (rTMS)
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 dTMSDevice
Sham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham dTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insula synaptic density
PET with UCB-J will be used to look at synaptic density pre/post intervention
Measured: 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
Measured: Change from Baseline at 3 weeks
Insula-centric functional connectivity
fMRI will be used to look at insula circuit functional connectivity pre/post intervention
Measured: Change from Baseline at 3 weeks
Secondary outcomes (3)
Symptoms of Psychosis
The positive and negative syndrome scale (PANSS) will be used to measure symptoms of schizophrenia
Measured: up to 4 times over 3 weeks
Nicotine Craving
Craving will be assessed using two self-report items
Measured: post dTMS over 3 weeks
Cigarettes per Day
Timeline Follow-back Calendars will be administered pre-dTMS and post-dTMS
Measured: Change from Baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start4 Apr 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Why it stopped: Funding was not renewed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After enrollment, participants will be randomized between-subjects to active dTMS or sham.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Anissa Abi-Dargham, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724810
- Sponsor's protocol ID
- 1R61DA056423
- Status last verified
- May 2025
- First submitted
- 27 Jan 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35217662
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
- ClinicalTrials.gov ID
- NCT05724810
- Acronym / sponsor ID
- 1R61DA056423
- Conditions
- Schizophrenia, Smoking Cessation, Tobacco Use
- Keywords
- PET, UCB-J, fMRI, Schizophrenia, Smoking Cessation, Tobacco Use
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was not renewed.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After enrollment, participants will be randomized between-subjects to active dTMS or sham.
| Arm | Type | Receives |
|---|---|---|
| Active deep transcranial magnetic stimulation (dTMS) | Experimental | Device: 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 | Sham comparator | Device: Sham dTMSActive 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active deep transcranial magnetic stimulation (dTMS)Also: repetitive transcranial magnetic stimulation (rTMS)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 | Active deep transcranial magnetic stimulation (dTMS) |
| Sham dTMSSham group will go through the same procedure. The only difference is that the sham card does not deliver stimulation. | Device | Sham |
Primary outcome
Insula synaptic density
Time frame: Change from Baseline at 3 weeks
PET with UCB-J will be used to look at synaptic density pre/post intervention
Smoking self-administration
Time frame: Change from Baseline at 3 weeks
Laboratory tobacco self-administration will be examined pre/post the intervention as a measure of smoking vigor
Insula-centric functional connectivity
Time frame: Change from Baseline at 3 weeks
fMRI will be used to look at insula circuit functional connectivity pre/post intervention
3 secondary outcomes
Symptoms of Psychosis
Time frame: up to 4 times over 3 weeks
Nicotine Craving
Time frame: post dTMS over 3 weeks
Cigarettes per Day
Time frame: Change from Baseline at 3 weeks
Results and safety
The study was stopped early (reason given: Funding was not renewed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 35217662Moeller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active deep transcranial magnetic stimulation (dTMS) in people with Schizophrenia and Smoking Cessation, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding was not renewed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insula synaptic density (time frame: Change from Baseline at 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.