To evaluate whether cue-induced nicotine craving and cognitive control in smoking individuals can be modulated with cTBS at left or right insula using deep TMS.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective cue-induced nicotine craving, measured by the Questionnaire on
Smoking Urges score after a smoking cue-exposure task, and behavioural
cognitive control, measured by the stop signal reaction time on the stop signal
task.
Secondary outcome
Physiological cue-induced nicotine craving and cognitive control, measured by
heart rate variability and skin conductance level.
Background summary
Tobacco use disorder is a mental health disorder characterized by the
compulsive urge to smoke, and smoking is the leading global risk factor for
premature death and disabilities. A brain area crucially involved in smoking
addiction is the insula, and the left and right insula appear to have opposite
roles in addictive processes. High frequency (HF) repetitive transcranial
magnetic stimulation (rTMS) is a non-invasive brain stimulation method found to
be effective in reducing nicotine craving and tobacco consumption, with
promising results of the novel techniques deep rTMS and theta burst stimulation
(TBS). Unfortunately, quit rates after deep HF rTMS at the bilateral frontal
cortex and insula in chronic smokers dropped to 19% after 4.5 month follow-up.
In our study, continuous TBS (cTBS) is used as a rTMS protocol in combination
with a deep TMS system that allows for unilateral stimulation, to investigate
the effect of inhibiting the insula on addictive processes, and the
differential role that the left and right insula play in this.
Study objective
To evaluate whether cue-induced nicotine craving and cognitive control in
smoking individuals can be modulated with cTBS at left or right insula using
deep TMS.
Study design
This study is a single-blind randomized sham-controlled intervention trial
using a single-session, mixed factorial, cross-over design.
Intervention
One group receives cTBS at the left insula, and the other group receives cTBS
at the right insula. Participants from both groups receive active and sham cTBS
for 20s each.
Study burden and risks
All participants will attend only a two hour single session. Possible negative
AEs of cTBS, including headaches and facial muscle twitching, as well as
possible beneficial effects of cTBS on cue-induced craving and cognitive
control, for the participants will only be transient. Results from this study
could be used for the better understanding of tobacco use disorder and further
development and improvement for the treatment of tobacco use disorder. Thus,
benefits of this study outweigh the low risks associated with study
participation.
De Boelelaan 1108
Amsterdam 1081 HZ
NL
De Boelelaan 1108
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Age of 18-30 year
Females: use of a medically accepted form of hormonal birth control
Smoking on average at least 10 filter cigarettes per day
Smoking for at least one year
Primarily smoking filter cigarettes and not any other form of tobacco
Exclusion criteria
Previous experience with (deep) rTMS
No reliable communication with the investigator or coping with the requirements
of the experiment possible
Last year or current psychiatric disorder diagnosis or treatment
Suffering from a neurological disorder
Possible alcohol dependence or drug (other than tobacco) use disorder diagnosis
TMS contraindications
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83625.018.23 |