SmokingPhase 2NCT05651334
Transcranial Magnetic Stimulation in Smokers: an Examination of Mediating Neural Pathways.
A Phase 2 study testing Active repetitive Transcranial Magnetic Stimulation in people with Smoking, run by Kent State University at 1 site in United States.
Trial summary
The primary objective of this study is to examine the effects of repetitive transcranial magnetic stimulation (rTMS) on a regulation of craving task (ROC task) and evaluate the feasibility of targeting rTMS via fMRI based neuronavigation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Active repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 13 Jul 2023
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smokers endorsing atleast moderate dependence (total Fagerstrom for Cigarette Dependence score > 4)
- Endorsing no specific plan to quit smoking in the next 3 months.
- Must meet safety guidelines for application of rTMS
- 18-60 years of age
- Smoked cigarettes regularly for at least one year
- Currently smoke at least 10 cigarettes per day
- Have a carbon monoxide (CO) level greater or equal to 10 ppm
- Currently be using no other nicotine products.
Who cannot join
- Subjects will be excluded if they meet criteria for current alcohol (moderate - severe), current substance dependence, current affective disorder (depression, dysthymia, or mania) or current psychotic symptoms as assessed by the (MINI) International Neuropsychiatric Exam
- Are currently pregnant or lactating, or intend to become pregnant
- Have a health condition for which rTMS is contraindicated
- Submit a urine drug screen positive for illicit substances or substance misuse.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to examine the effects of repetitive transcranial magnetic stimulation (rTMS) on a regulation of craving task (ROC task) and evaluate the feasibility of targeting rTMS via fMRI based neuronavigation. Specifically, we will examine BOLD activation within the DLPFC when control over craving is exerted in order to identify if 1) the task produces reliable activations in an area capable of being targeted by a standard figure-8 coil and 2) examine if the coordinates of the area are distinct from the area targeted via anatomical neuronavigation alone. Last, we will examine if rTMS, compared to sham, is capable of improving cognitive control over craving measured at outcome. The current pilot study will examine these aims in a sample of tobacco dependent adults (N=16) (with final sample size dependent on availability of funds).
Read the detailed description
The study will include functional magnetic resonance imaging at baseline as well as demographic, psychological, and tobacco use assessments. Following initial assessment, participants will undergo one active rTMS session (20 Hz rTMS, 900 pulses per session, applied to left DLPFC). The outcome session will include assessments repeated from baseline.
The current proposal will examine the following aims. Aim 1: To test the potential for active rTMS to improve cognitive control of craving. Hypothesis: Active rTMS (compared to sham rTMS) will result in significant improvement in control over craving assessed by self-reported craving during the ROC task as well as in terms of activity in prefrontal regions associated with cognitive control during the ROC task.
Aim 2 (feasibility): To examine the feasibility of using fMRI BOLD activation in the DLPFC during the ROC task to target rTMS. BOLD activations during successful control over craving trials will be examined in terms of their reliability within participant and their feasibility as a target for rTMS delivered via standard figure 8 coil (capable of inducing synaptic firing 1.5-3.0 cm beneath the scalp). Additionally, the coordinates for the target identified via BOLD activation during the ROC task will be compared to the coordinates for the target identified by using standard neuronavigation to the DLPFC via anatomical fMRI, in order to determine if these areas are distinct in terms of the direct effect of the stimulation field (approximately 5 cm2).
- Conditions
- Smoking
- Being tested
- Active repetitive Transcranial Magnetic Stimulation, Sham repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive Transcranial Magnetic StimulationDevice
Active stimulation
Sham repetitive Transcranial Magnetic StimulationDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | rTMS will be delivered with a MagPro R-30 magnetic stimulator (MagVenture, Farum, Denmark) Cool-B65 A/P (Active/Placebo). Participants will receive 900 pulses of 20 Hz rTMS per session at 110% of the Motor threshold (MT) (45 20-pulse trains of 1 second duration with an inter-train interval of 20 seconds). MT will be established to determine the intensity of stimulation for each participant, as recommended by safety guidelines. MT will be defined as the amount of energy required to induce a visible twitch in contralateral hand in at least 50% of stimulations. The target stimulation site will be the left DLPFC, specifically: located 6 cm anterior of the MT site identified with assistance from the neuro-navigation system to ensure that the target is located in the middle of the frontal gyrus, in the lateral part of Brodmann Area (BA) 9, near the border of BA 46. Receives: Device: Active repetitive Transcranial Magnetic Stimulation |
| Sham repetitive Transcranial Magnetic Stimulation (rTMS) | Sham comparator | Sham rTMS will appear identical to active treatment, with the exception that the sham side of the coil will be used resulting in no stimulation being applied to the participant, while providing a sensation of stimulation. Receives: Device: Sham repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulation of Craving Task
Self report ratings of cue induced craving for smoking after instruction. Specifically, differences in craving following positive vs. negative instructions will be compared between active stimulation and sham stimulation groups at the final outcome session, accounting for baseline values (similar to methods detailed in (Kober, Kross, Mischel, Hart, \& Ochsner, 2010).
Kober, H., Kross, E. F., Mischel, W., Hart, C. L., \& Ochsner, K. N. (2010). Regulation of craving by cognitive strategies in cigarette smokers. Drug and Alcohol Dependence, 106(1), 52-55. doi:10.1016/j.drugalcdep.2009.07.017
Measured: Assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. Primary outcome measure are the ratings collected at the final outcome session.
Brief Questionnaire of Smoking Urges (QSU - Brief)
Self report assessment smoking urges will be compared between active stimulation and sham stimulation groups at the final outcome session, accounting for baseline values.
Measured: Assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. Primary outcome measure are the ratings collected at the final outcome session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start8 Nov 2022
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to active or sham transcranial magnetic stimulation. Assignment to condition will be conducted using the Urn randomization procedure to ensure balancing on nicotine dependence, and age.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, William Lechner. PhD, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651334
- Sponsor's protocol ID
- 18-604
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: NO IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation in Smokers: an Examination of Mediating Neural Pathways.
- ClinicalTrials.gov ID
- NCT05651334
- Acronym / sponsor ID
- 18-604
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 15 Dec 2022 (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 primary objective of this study is to examine the effects of repetitive transcranial magnetic stimulation (rTMS) on a regulation of craving task (ROC task) and evaluate the feasibility of targeting rTMS via fMRI based neuronavigation. Specifically, we will examine BOLD activation within the DLPFC when control over craving is exerted in order to identify if 1) the task produces reliable activations in an area capable of being targeted by a standard figure-8 coil and 2) examine if the coordinates of the area are distinct from the area targeted via anatomical neuronavigation alone. Last, we will examine if rTMS, compared to sham, is capable of improving cognitive control over craving measured at outcome. The current pilot study will examine these aims in a sample of tobacco dependent adults (N=16) (with final sample size dependent on availability of funds).
Detailed description
The study will include functional magnetic resonance imaging at baseline as well as demographic, psychological, and tobacco use assessments. Following initial assessment, participants will undergo one active rTMS session (20 Hz rTMS, 900 pulses per session, applied to left DLPFC). The outcome session will include assessments repeated from baseline.
The current proposal will examine the following aims. Aim 1: To test the potential for active rTMS to improve cognitive control of craving. Hypothesis: Active rTMS (compared to sham rTMS) will result in significant improvement in control over craving assessed by self-reported craving during the ROC task as well as in terms of activity in prefrontal regions associated with cognitive control during the ROC task.
Aim 2 (feasibility): To examine the feasibility of using fMRI BOLD activation in the DLPFC during the ROC task to target rTMS. BOLD activations during successful control over craving trials will be examined in terms of their reliability within participant and their feasibility as a target for rTMS delivered via standard figure 8 coil (capable of inducing synaptic firing 1.5-3.0 cm beneath the scalp). Additionally, the coordinates for the target identified via BOLD activation during the ROC task will be compared to the coordinates for the target identified by using standard neuronavigation to the DLPFC via anatomical fMRI, in order to determine if these areas are distinct in terms of the direct effect of the stimulation field (approximately 5 cm2).
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
- Participants will be randomly assigned to active or sham transcranial magnetic stimulation. Assignment to condition will be conducted using the Urn randomization procedure to ensure balancing on nicotine dependence, and age.
| Arm | Type | Receives |
|---|---|---|
| Active repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Device: Active repetitive Transcranial Magnetic StimulationrTMS will be delivered with a MagPro R-30 magnetic stimulator (MagVenture, Farum, Denmark) Cool-B65 A/P (Active/Placebo). Participants will receive 900 pulses of 20 Hz rTMS per session at 110% of the Motor threshold (MT) (45 20-pulse trains of 1 second duration with an inter-train interval of 20 seconds). MT will be established to determine the intensity of stimulation for each participant, as recommended by safety guidelines. MT will be defined as the amount of energy required to induce a visible twitch in contralateral hand in at least 50% of stimulations. The target stimulation site will be the left DLPFC, specifically: located 6 cm anterior of the MT site identified with assistance from the neuro-navigation system to ensure that the target is located in the middle of the frontal gyrus, in the lateral part of Brodmann Area (BA) 9, near the border of BA 46. |
| Sham repetitive Transcranial Magnetic Stimulation (rTMS) | Sham comparator | Device: Sham repetitive Transcranial Magnetic StimulationSham rTMS will appear identical to active treatment, with the exception that the sham side of the coil will be used resulting in no stimulation being applied to the participant, while providing a sensation of stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Smokers endorsing atleast moderate dependence (total Fagerstrom for Cigarette Dependence score > 4)
- Endorsing no specific plan to quit smoking in the next 3 months.
- Must meet safety guidelines for application of rTMS
- 18-60 years of age
- Smoked cigarettes regularly for at least one year
Key exclusion criteria (4 listed)
- Subjects will be excluded if they meet criteria for current alcohol (moderate - severe), current substance dependence, current affective disorder (depression, dysthymia, or mania) or current psychotic symptoms as assessed by the (MINI) International Neuropsychiatric Exam
- Are currently pregnant or lactating, or intend to become pregnant
- Have a health condition for which rTMS is contraindicated
- Submit a urine drug screen positive for illicit substances or substance misuse.
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 repetitive Transcranial Magnetic StimulationActive stimulation | Device | Active repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham repetitive Transcranial Magnetic StimulationSham stimulation | Device | Sham repetitive Transcranial Magnetic Stimulation (rTMS) |
Primary outcome
Regulation of Craving Task
Time frame: Assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. Primary outcome measure are the ratings collected at the final outcome session.
Self report ratings of cue induced craving for smoking after instruction. Specifically, differences in craving following positive vs. negative instructions will be compared between active stimulation and sham stimulation groups at the final outcome session, accounting for baseline values (similar to methods detailed in (Kober, Kross, Mischel, Hart, \& Ochsner, 2010). Kober, H., Kross, E. F., Mischel, W., Hart, C. L., \& Ochsner, K. N. (2010). Regulation of craving by cognitive strategies in cigarette smokers. Drug and Alcohol Dependence, 106(1), 52-55. doi:10.1016/j.drugalcdep.2009.07.017
Brief Questionnaire of Smoking Urges (QSU - Brief)
Time frame: Assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. Primary outcome measure are the ratings collected at the final outcome session.
Self report assessment smoking urges will be compared between active stimulation and sham stimulation groups at the final outcome session, accounting for baseline values.
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 8 Mar 2024.
- Individual participant dataSharing planned: No. NO IPD will be shared.
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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 Phase 2 study testing Active repetitive Transcranial Magnetic Stimulation in people with Smoking, run by Kent State 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 8 inclusion and 4 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 8 Mar 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Regulation of Craving Task (time frame: Assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. Primary outcome measure are the ratings collected at the final outcome session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2024.