SchizophreniaNCT06389266
Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Schizophrenia and Nicotine Dependence, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Nicotine Dependence
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 22 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- Diagnosis of either schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria and confirmed by Structured Clinical Interview for the DSM (SCID) (First et al. 2015)
- Current nicotine use (confirmed by expired carbon monoxide or urine cotinine)
- Must be able to read, speak and understand English
- Must be judged by study staff to be capable of completing the study procedures
- Participants will be in stable outpatient psychiatric treatment and psychiatrically stable with no recent (within the past 90 days) psychiatric hospitalizations or changes in their psychiatric medication regimens.
- All of the above except for participants will not have a diagnosis of schizophrenia or schizoaffective disorder nor a first-degree relative with a psychotic disorder.
Who cannot join
- DSM-5 intellectual disability
- Substance use disorder (other than nicotine) within the past three months Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
- Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
- History of head trauma resulting in any loss of consciousness (>15 minutes) or neurological sequelae
- Current history of poorly controlled headaches including chronic medication for migraine prevention
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
Show all 14Show fewer
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
- Any devices such as pacemaker, medication pump, nerve stimulator, transcutaneous electrical nerve stimulation (TENS) unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
- All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study
- Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of central nervous system (CNS) active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.
- Any changes in medications or hospitalizations within the past 90 days.
- Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are:
- Can rTMS change functional connectivity in brain circuits associated with nicotine use?
- Are those rTMS-induced changes in functional connectivity related to craving?
Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving.
Read the detailed description
This study proposes to test the hypothesis that the brain circuits most relevant to nicotine use in schizophrenia are distinct from pathways identified in nicotine-using people without psychosis. This study seeks to provide evidence that targeted stimulation of the Default Mode Network (DMN) leads to both altered network activity and a concomitant behavioral change in cue-induced craving and cognitive performance in individuals with schizophrenia and schizoaffective disorder, while targeted stimulation of the left dorsolateral prefrontal cortex (L DLPFC) leads to these changes in nicotine-using people without psychosis.
The investigators will test this hypothesis in a crossover design comparing 1) DMN-targeted continuous theta burst stimulation (cTBS) and 2) L DLPFC-targeted intermittent theta burst stimulation (iTBS). cTBS and iTBS are types of rTMS. cTBS has inhibitory effects and reduces functional connectivity, while iTBS is excitatory and increases connectivity (Huang et al. 2005). By applying cTBS to the DMN, a target that modulates craving in schizophrenia, the investigators expect DMN connectivity to decrease, thereby decreasing craving. Excitatory stimulation (e.g. iTBS) to the L DLPFC reduces craving in smokers without psychosis (Tseng et al. 2022).
This study will test a model that integrates brain network pathophysiology and cognition to 1) explain the prevalence of nicotine use in schizophrenia and 2) identify a target for engagement in schizophrenia. This study seeks to establish a neuroscientific framework to guide future treatment-oriented studies aimed at reducing craving and improving cognitive performance in individuals with schizophrenia and schizoaffective disorder.
Aim 1: Target Engagement: Determine if rTMS manipulates functional connectivity of each target (DMN, L DLPFC) (n=60). Hypothesis 1A: Functional connectivity of the entire DMN will decrease after 5 days of DMN-targeted cTBS. Hypothesis 1B: Functional connectivity of the L DLPFC to the left insula will increase after 5 days of L DLPFC-targeted iTBS. As an exploratory hypothesis, the investigators will test if there is an effect of diagnosis on connectivity change.
Aim 2: Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=60). Hypothesis 2A: Both DMN-targeted and L DLPFC-targeted rTMS will significantly reduce craving. Hypothesis 2B: Craving change will be correlated with functional connectivity change. As an exploratory hypothesis, in individuals with schizophrenia, DMN-targeted cTBS will be more efficacious than L DLPFC-targeted iTBS.
Aim 3: Determine if individual differences in rTMS-induced network connectivity change are explained by individual differences in network controllability (n=60). There is significant heterogeneity in individual response to rTMS, even with network-targeted approaches. This may be related to network controllability, a metric of the average input energy required to change brain state (Bassett and Sporns 2017). It is critical to understand predictors of network change for optimal rTMS target selection in clinical trials. Hypothesis 3: Individual differences in rTMS-induced change in DMN connectivity will be associated with average controllability of the DMN rTMS stimulation site.
- Conditions
- Schizophrenia, Nicotine Dependence
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Schizophrenia, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
rTMS is a technique of TMS that allows the selective external manipulation of neural activity in a non-invasive manner. During TMS, a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field that in turn induces electrical current in neurons and allows the modulation of neural circuitry. The combination of rTMS with functional magnetic resonance imaging allows the selective targeting and modulation of brain networks. The repeated application of rTMS can cause long term changes in behavior and task performance that is reflected in altered brain network connectivity.
| Study group | Role | What they receive |
|---|---|---|
| L DLPFC-Targeted iTBS, Then DMN-Targeted cTBS | Active comparator | Participants will first receive intermittent theta burst stimulation (iTBS) at 100% active motor threshold (AMT) anatomically targeted to the left dorsolateral prefrontal cortex for five consecutive days. iTBS will be administered in a pattern consisting of 2s trains of 3 pulses at 50Hz, repeated at 5Hz, every 10s for a total of 600 pulses. There will then be a washout period of at least two weeks before starting the DMN-Targeted cTBS. Participants will then receive continuous theta burst stimulation (cTBS) at 100% AMT targeted to an individual-specific map of the left parietal node of the default mode network for five consecutive days. cTBS will be administered in a pattern consisting of 1 60s train of 3 pulses at 50Hz, repeated at 5Hz, for a total of 600 pulses. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| DMN-Targeted cTBS, Then L DLPFC-Targeted iTBS | Active comparator | Participants will first receive continuous theta burst stimulation (cTBS) at 100% AMT targeted to an individual-specific map of the left parietal node of the default mode network for five consecutive days. cTBS will be administered in a pattern consisting of 1 60s train of 3 pulses at 50Hz, repeated at 5Hz, for a total of 600 pulses. There will then be a washout period of at least two weeks before starting the L DLPFC-Targeted iTBS. Participants will receive intermittent theta burst stimulation (iTBS) at 100% active motor threshold (AMT) anatomically targeted to the left dorsolateral prefrontal cortex for five consecutive days. iTBS will be administered in a pattern consisting of 2s trains of 3 pulses at 50Hz, repeated at 5Hz, every 10s for a total of 600 pulses. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-state functional connectivity
The investigators will evaluate the effect of DMN-targeted cTBS on functional connectivity of the left parietal node of the DMN and the entire default mode network. The investigators will also evaluate the effect of L DLPFC-targeted iTBS on functional connectivity of the L DLPFC.
Measured: Baseline to one week, and three weeks to five weeks
Cue-induced craving
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on self-reported craving before and after presentation of visual nicotine cues. Craving is measured on a scale from 0 to 10, with 10 being the highest level of craving.
Measured: Baseline to one week, and three weeks to five weeks
Tiffany Brief Questionnaire of Smoking Urges (QSU)
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on QSU scores. The QSU-Brief has a range of 10-70, with higher scores indicating higher smoking urges.
Measured: Baseline to one week, and three weeks to five weeks
Self-reported craving
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on self-reported craving, measured by a Visual Analog Scale of nicotine craving. Craving is measured on a scale from 0 to 10, with 10 being the highest level of craving.
Measured: Baseline to one week, and three weeks to five weeks
Secondary outcomes (3)
Wisconsin Smoking Withdrawal Scale (WSWS)
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on self-reported withdrawal symptoms.The WSWS has a range of 0-112, with higher scores indicating higher withdrawal.
Measured: Baseline to one week, and three weeks to five weeks
Fagerstrom Test for Nicotine Dependence (FTND)
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on nicotine dependence severity. The FTND has a range of 0-10, with higher scores indicating greater nicotine dependence.
Measured: Baseline to one week, and three weeks to five weeks
Self-reported nicotine use
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on self-reported nicotine use, measured by the Timeline Follow Back and the Recent Substance Use Questionnaire.
Measured: Baseline to one week, and three weeks to five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start15 Jun 2023
- Primary completion15 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive five days of DMN-targeted cTBS and five days of L DLPFC-targeted iTBS. The order in which participants receive the two types of TMS is randomized.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Burrell Ward, Vanderbilt University Medical Center
- Investigators
- Heather B Ward, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389266
- Sponsor's protocol ID
- 221550
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
PubMed 15664172Tseng PT, Zeng BS, Hung CM, Liang CS, Stubbs B, Carvalho AF, Brunoni AR, Su KP, Tu YK, Wu YC, Chen TY, Li DJ, Lin PY, Hsu CW, Chen YW, Suen MW, Satogami K, Takahashi S, Wu CK, Yang WC, Shiue YL, Huang TL, Li CT. Assessment of Noninvasive Brain Stimulation Interventions for Negative Symptoms of Schizophrenia: A Systematic Review and Network Meta-analysis. JAMA Psychiatry. 2022 Aug 1;79(8):770-779. doi: 10.1001/jamapsychiatry.2022.1513.
PubMed 35731533Bassett DS, Sporns O. Network neuroscience. Nat Neurosci. 2017 Feb 23;20(3):353-364. doi: 10.1038/nn.4502.
PubMed 28230844
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia
- ClinicalTrials.gov ID
- NCT06389266
- Acronym / sponsor ID
- 221550
- Conditions
- Schizophrenia, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 29 Apr 2024 (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.
The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are:
- Can rTMS change functional connectivity in brain circuits associated with nicotine use?
- Are those rTMS-induced changes in functional connectivity related to craving?
Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving.
Detailed description
This study proposes to test the hypothesis that the brain circuits most relevant to nicotine use in schizophrenia are distinct from pathways identified in nicotine-using people without psychosis. This study seeks to provide evidence that targeted stimulation of the Default Mode Network (DMN) leads to both altered network activity and a concomitant behavioral change in cue-induced craving and cognitive performance in individuals with schizophrenia and schizoaffective disorder, while targeted stimulation of the left dorsolateral prefrontal cortex (L DLPFC) leads to these changes in nicotine-using people without psychosis.
The investigators will test this hypothesis in a crossover design comparing 1) DMN-targeted continuous theta burst stimulation (cTBS) and 2) L DLPFC-targeted intermittent theta burst stimulation (iTBS). cTBS and iTBS are types of rTMS. cTBS has inhibitory effects and reduces functional connectivity, while iTBS is excitatory and increases connectivity (Huang et al. 2005). By applying cTBS to the DMN, a target that modulates craving in schizophrenia, the investigators expect DMN connectivity to decrease, thereby decreasing craving. Excitatory stimulation (e.g. iTBS) to the L DLPFC reduces craving in smokers without psychosis (Tseng et al. 2022).
This study will test a model that integrates brain network pathophysiology and cognition to 1) explain the prevalence of nicotine use in schizophrenia and 2) identify a target for engagement in schizophrenia. This study seeks to establish a neuroscientific framework to guide future treatment-oriented studies aimed at reducing craving and improving cognitive performance in individuals with schizophrenia and schizoaffective disorder.
Aim 1: Target Engagement: Determine if rTMS manipulates functional connectivity of each target (DMN, L DLPFC) (n=60). Hypothesis 1A: Functional connectivity of the entire DMN will decrease after 5 days of DMN-targeted cTBS. Hypothesis 1B: Functional connectivity of the L DLPFC to the left insula will increase after 5 days of L DLPFC-targeted iTBS. As an exploratory hypothesis, the investigators will test if there is an effect of diagnosis on connectivity change.
Aim 2: Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=60). Hypothesis 2A: Both DMN-targeted and L DLPFC-targeted rTMS will significantly reduce craving. Hypothesis 2B: Craving change will be correlated with functional connectivity change. As an exploratory hypothesis, in individuals with schizophrenia, DMN-targeted cTBS will be more efficacious than L DLPFC-targeted iTBS.
Aim 3: Determine if individual differences in rTMS-induced network connectivity change are explained by individual differences in network controllability (n=60). There is significant heterogeneity in individual response to rTMS, even with network-targeted approaches. This may be related to network controllability, a metric of the average input energy required to change brain state (Bassett and Sporns 2017). It is critical to understand predictors of network change for optimal rTMS target selection in clinical trials. Hypothesis 3: Individual differences in rTMS-induced change in DMN connectivity will be associated with average controllability of the DMN rTMS stimulation site.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants receive five days of DMN-targeted cTBS and five days of L DLPFC-targeted iTBS. The order in which participants receive the two types of TMS is randomized.
| Arm | Type | Receives |
|---|---|---|
| L DLPFC-Targeted iTBS, Then DMN-Targeted cTBS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will first receive intermittent theta burst stimulation (iTBS) at 100% active motor threshold (AMT) anatomically targeted to the left dorsolateral prefrontal cortex for five consecutive days. iTBS will be administered in a pattern consisting of 2s trains of 3 pulses at 50Hz, repeated at 5Hz, every 10s for a total of 600 pulses. There will then be a washout period of at least two weeks before starting the DMN-Targeted cTBS. Participants will then receive continuous theta burst stimulation (cTBS) at 100% AMT targeted to an individual-specific map of the left parietal node of the default mode network for five consecutive days. cTBS will be administered in a pattern consisting of 1 60s train of 3 pulses at 50Hz, repeated at 5Hz, for a total of 600 pulses. |
| DMN-Targeted cTBS, Then L DLPFC-Targeted iTBS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will first receive continuous theta burst stimulation (cTBS) at 100% AMT targeted to an individual-specific map of the left parietal node of the default mode network for five consecutive days. cTBS will be administered in a pattern consisting of 1 60s train of 3 pulses at 50Hz, repeated at 5Hz, for a total of 600 pulses. There will then be a washout period of at least two weeks before starting the L DLPFC-Targeted iTBS. Participants will receive intermittent theta burst stimulation (iTBS) at 100% active motor threshold (AMT) anatomically targeted to the left dorsolateral prefrontal cortex for five consecutive days. iTBS will be administered in a pattern consisting of 2s trains of 3 pulses at 50Hz, repeated at 5Hz, every 10s for a total of 600 pulses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18-65 years
- Diagnosis of either schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria and confirmed by Structured Clinical Interview for the DSM (SCID) (First et al. 2015)
- Current nicotine use (confirmed by expired carbon monoxide or urine cotinine)
- Must be able to read, speak and understand English
- Must be judged by study staff to be capable of completing the study procedures
Key exclusion criteria (14 listed)
- DSM-5 intellectual disability
- Substance use disorder (other than nicotine) within the past three months Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
- Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
- History of head trauma resulting in any loss of consciousness (>15 minutes) or neurological sequelae
- Current history of poorly controlled headaches including chronic medication for migraine prevention
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)rTMS is a technique of TMS that allows the selective external manipulation of neural activity in a non-invasive manner. During TMS, a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field that in turn induces electrical current in neurons and allows the modulation of neural circuitry. The combination of rTMS with functional magnetic resonance imaging allows the selective targeting and modulation of brain networks. The repeated application of rTMS can cause long term changes in behavior and task performance that is reflected in altered brain network connectivity. | Device | DMN-Targeted cTBS, Then L DLPFC-Targeted iTBS, L DLPFC-Targeted iTBS, Then DMN-Targeted cTBS |
Primary outcome
Resting-state functional connectivity
Time frame: Baseline to one week, and three weeks to five weeks
The investigators will evaluate the effect of DMN-targeted cTBS on functional connectivity of the left parietal node of the DMN and the entire default mode network. The investigators will also evaluate the effect of L DLPFC-targeted iTBS on functional connectivity of the L DLPFC.
Cue-induced craving
Time frame: Baseline to one week, and three weeks to five weeks
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on self-reported craving before and after presentation of visual nicotine cues. Craving is measured on a scale from 0 to 10, with 10 being the highest level of craving.
Tiffany Brief Questionnaire of Smoking Urges (QSU)
Time frame: Baseline to one week, and three weeks to five weeks
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on QSU scores. The QSU-Brief has a range of 10-70, with higher scores indicating higher smoking urges.
Self-reported craving
Time frame: Baseline to one week, and three weeks to five weeks
The investigators will evaluate the effect of DMN-targeted cTBS and L DLPFC-targeted iTBS on self-reported craving, measured by a Visual Analog Scale of nicotine craving. Craving is measured on a scale from 0 to 10, with 10 being the highest level of craving.
3 secondary outcomes
Wisconsin Smoking Withdrawal Scale (WSWS)
Time frame: Baseline to one week, and three weeks to five weeks
Fagerstrom Test for Nicotine Dependence (FTND)
Time frame: Baseline to one week, and three weeks to five weeks
Self-reported nicotine use
Time frame: Baseline to one week, and three weeks to five weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 15664172Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
- Background: PubMed 35731533Tseng PT, Zeng BS, Hung CM, Liang CS, Stubbs B, Carvalho AF, Brunoni AR, Su KP, Tu YK, Wu YC, Chen TY, Li DJ, Lin PY, Hsu CW, Chen YW, Suen MW, Satogami K, Takahashi S, Wu CK, Yang WC, Shiue YL, Huang TL, Li CT. Assessment of Noninvasive Brain Stimulation Interventions for Negative Symptoms of Schizophrenia: A Systematic Review and Network Meta-analysis. JAMA Psychiatry. 2022 Aug 1;79(8):770-779. doi: 10.1001/jamapsychiatry.2022.1513.
- Background: PubMed 28230844Bassett DS, Sporns O. Network neuroscience. Nat Neurosci. 2017 Feb 23;20(3):353-364. doi: 10.1038/nn.4502.
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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.
Heather B Ward, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Schizophrenia and Nicotine Dependence, run by Vanderbilt University Medical Center 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 7 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: finished, as of the sponsor's last update on 17 Dec 2025. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resting-state functional connectivity (time frame: Baseline to one week, and three weeks to five weeks). The study lists 4 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 NCT06389266, which also lists 3 linked publications.
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 17 Dec 2025.