Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05152810
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2021-11-24
Brief Title:
Effectiveness of Transcranial Magnetic Stimulation TMS in Smoking Cessation Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Efficacy of Transcranial Magnetic Stimulation TMS in Smoking Cessation Combining Withdrawal Stimulations Followed by Maintenance Stimulations to Prevent Relapse a Single-center Randomized Controlled Blinded Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
TABACSTIM 3
Brief Summary:
Smoking cessation is a public health priority Tobacco is directly responsible for 75000 deaths per year in France Without help less than 5 of smokers are still abstinent after 12 months of smoking cessation The use of nicotine replacement therapy only increases the chances of successful smoking cessation by 2-3
Brain imaging research shows that the dorsolateral prefrontal cortex DLPC is involved in tobacco addiction Disorders induced in the DLPC cause an irrepressible urge to smoke craving and largely explain relapse during smoking cessation
Transcranial Magnetic Stimulation TMS could be a promising tool in the quest for an effective approach to smoking cessation This technique is used for direct stimulation of the DLPC via a magnetic coil in order to reduce the cortical activity of the DLPC and thus to reduce cravings
A first randomized controlled study using TMS was conducted at the University Hospital of Dijon in highly addicted smokers who had failed to quit with the usual withdrawal strategies In this study entitled Tabacstim 1 we found that the combination of nicotine substitutes to reduce physical withdrawal symptoms with 10 attack sessions of TMS to reduce cravings increased the rate of abstinence during the first 2 weeks of withdrawal abstinence 88 However in this study the therapeutic effect of the nicotine-SMT combination was not prolonged once the stimuli were stopped At 6 and 12 weeks from the start of withdrawal abstinence rates in the active SMT and placebo SMT groups were no longer significantly different
We therefore initiated a new study entitled Tabacstim 2 to add maintenance brain stimulation to the Tabacstim 1 protocol after the attack sessions this therapeutic scheme is classically used in the treatment of depression with TMS This study started in July 2020 and will end very soon 71 inclusions completed out of the 78 expected
In both Tabacstim 1 and Tabacstim 2 the stimulations are delivered at low frequency 1 Hz on the right DLPC However a recently published meta-analysis shows that in addictions stimulations delivered at a high frequency 10 Hz on the left DLPC appear to be more effective in reducing craving But above all another meta-analysis carried out by our team in progress of publication finds that excitatory stimulations such as 10 Hz rTMS on the left DLPC are very effective in maintaining smoking abstinence in the medium term 3 and 6 months which does not seem to be the case for inhibitory stimulations such as 1 Hz rTMS
We therefore wish to carry out the Tabacstim 3 study which only differs from Tabacstim 2 in two stimulation parameters 10 Hz stimulations on the left DLPC instead of 1 Hz stimulations on the right DLPC We therefore propose in Tabacstim 3 to use excitatory stimulations on the left instead of inhibitory stimulations on the right
Tabacstim 3 could be more effective for prolonged smoking cessation than the 2 previous protocols
Brain imaging research shows that the dorsolateral prefrontal cortex DLPC is involved in tobacco addiction Disorders induced in the DLPC cause an irrepressible urge to smoke craving and largely explain relapse during smoking cessation
Transcranial Magnetic Stimulation TMS could be a promising tool in the quest for an effective approach to smoking cessation This technique is used for direct stimulation of the DLPC via a magnetic coil in order to reduce the cortical activity of the DLPC and thus to reduce cravings
A first randomized controlled study using TMS was conducted at the University Hospital of Dijon in highly addicted smokers who had failed to quit with the usual withdrawal strategies In this study entitled Tabacstim 1 we found that the combination of nicotine substitutes to reduce physical withdrawal symptoms with 10 attack sessions of TMS to reduce cravings increased the rate of abstinence during the first 2 weeks of withdrawal abstinence 88 However in this study the therapeutic effect of the nicotine-SMT combination was not prolonged once the stimuli were stopped At 6 and 12 weeks from the start of withdrawal abstinence rates in the active SMT and placebo SMT groups were no longer significantly different
We therefore initiated a new study entitled Tabacstim 2 to add maintenance brain stimulation to the Tabacstim 1 protocol after the attack sessions this therapeutic scheme is classically used in the treatment of depression with TMS This study started in July 2020 and will end very soon 71 inclusions completed out of the 78 expected
In both Tabacstim 1 and Tabacstim 2 the stimulations are delivered at low frequency 1 Hz on the right DLPC However a recently published meta-analysis shows that in addictions stimulations delivered at a high frequency 10 Hz on the left DLPC appear to be more effective in reducing craving But above all another meta-analysis carried out by our team in progress of publication finds that excitatory stimulations such as 10 Hz rTMS on the left DLPC are very effective in maintaining smoking abstinence in the medium term 3 and 6 months which does not seem to be the case for inhibitory stimulations such as 1 Hz rTMS
We therefore wish to carry out the Tabacstim 3 study which only differs from Tabacstim 2 in two stimulation parameters 10 Hz stimulations on the left DLPC instead of 1 Hz stimulations on the right DLPC We therefore propose in Tabacstim 3 to use excitatory stimulations on the left instead of inhibitory stimulations on the right
Tabacstim 3 could be more effective for prolonged smoking cessation than the 2 previous protocols
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None