Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05651334
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2022-11-28
Brief Title:
Transcranial Magnetic Stimulation in Smokers an Examination of Mediating Neural Pathways
Sponsor:
Kent State University
Organization:
Kent State University
Study Overview
Official Title:
Transcranial Magnetic Stimulation in Smokers an Examination of Mediating Neural Pathways
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N16 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 15-30 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
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 15-30 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None