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

NCT ID: NCT05651334

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2023-07-13

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active repetitive Transcranial Magnetic Stimulation (rTMS)

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.

Group Type: EXPERIMENTAL

Active repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Active stimulation

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

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.

Group Type: SHAM_COMPARATOR

Sham repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Sham stimulation

Interventions

Active repetitive Transcranial Magnetic Stimulation

Active stimulation

Intervention Type: DEVICE

Sham repetitive Transcranial Magnetic Stimulation

Sham stimulation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Kent State University

OTHER

Sponsor Role: lead

Responsible Party

William Lechner. PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

18-604

Identifier Type: -

Identifier Source: org_study_id