Transcranial Magnetic Stimulation in Smokers: an Examination of Mediating Neural Pathways.

Smoking Clinical Trial

Official title:

Transcranial Magnetic Stimulation in Smokers: an Examination of Mediating Neural Pathways.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05651334
• Other study ID #: 18-604
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2022
• Est. completion date: July 13, 2023

Study information

• Verified date: March 2024
• Source: Kent State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Smoking

Intervention

Device:
• Active repetitive Transcranial Magnetic Stimulation
Active stimulation
• Sham repetitive Transcranial Magnetic Stimulation
Sham stimulation

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kent State University	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Primary	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.	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.