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

NCT05651334 | Completed Phase 2 FDA Device

• 1 other identifier: 18-604
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

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.

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.

Device: Sham repetitive Transcranial Magnetic Stimulation

Interventions

Active repetitive Transcranial Magnetic Stimulation DEVICE

Active stimulation

Active repetitive Transcranial Magnetic Stimulation (rTMS)

Sham repetitive Transcranial Magnetic Stimulation DEVICE

Sham stimulation

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kent State University: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Condition assignment using the URN procedure will be conducted by the research coordinator who is not involved in treatment delivery or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 15, 2022
• Study Start: November 8, 2022
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)