Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT05651334
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).
Looking for future studies?
Notify MeThe 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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active stimulation
Sham stimulation
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
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.
Kent State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03968900
Behavior, Chemically-Induced Disorders
Birmingham, Alabama, United States
View Trial DetailsNCT02779127
Behavior, Smoking
Toulouse, France
View Trial DetailsNCT03978442
Behavior, Mental Disorders
Durham, North Carolina, United States
View Trial DetailsNCT05490927
Behavior, Discrimination, Racial
Houston, Texas, United States
View Trial Details