The aim of the study is to investigate whether inhibition of the left or right insula has differential effects with regard to clinical outcomes (i.e. smoking cessation/reduction), cognitive processes (i.e. cognitive control, craving and goal-…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Days untill relapse, number of smoked cigarettes and craving
Secondary outcome
Abstinence (yes/no), number of abstinent days, degree of tobacco dependence,
withdrawal symptoms, cognitive control, craving, goal-directed behavior,
neurobiological measures (brain network activity, brain activity involved in
cognitive control and craving, dACC glutamate concentrations), craving after
cTBS session.
Background summary
Tobacco use disorder is associated with deviating cognitive functions,
including cognitive control and craving. A brain area that is associated with
these addiction-related cognitive functions is the insula, but there appears to
be a functional lateralization. These neurocognitive deviations give rise to
the development of novel treatment strategies. One promising strategy is
transcranial magnetic stimulation (TMS), by which specific (cortical) brain
areas can be targeted to either increase or decrease neural activity and
thereby normalize cognitive functioning. Recently a novel approach has been
developed by which deeper brain areas can be targeted; deep TMS. It has been
suggested that inhibiting, rather than stimulating the insula, might have
stronger clinical potential. Continuous theta burst stimulation (cTBS), a form
of TMS, results in neural inhibition and can be targeted at the insula with the
use of an innovative H8 TMS coil.
It is expected that inhibition of left and right insula will show differential
effectiveness on outcomes and that there will be sex differences.
Study objective
The aim of the study is to investigate whether inhibition of the left or right
insula has differential effects with regard to clinical outcomes (i.e. smoking
cessation/reduction), cognitive processes (i.e. cognitive control, craving and
goal-directed action) and underlying neurobiological processes (i.e. brain
network activity, activity associated with cognitive control and craving, and
glutamate concentrations in the dorsal ACC). Sex-related differences in the
outcomes will also be investigated.
Study design
double-blind RCT
Intervention
Participants are randomized to 1 of 3 conditions; 1) active cTBS of the left
insula, 2) active cTBS of the right insula, or 3) sham stimulation of the left
or right insula. All participants will receive additional motivational
interviewing.
Study burden and risks
Potential negative side effects of cTBS, including headaches and facial
twitching, will only be temporary for participants. The results of this
research can be used for a better understanding of tobacco addiction and for
further development and improvement of the treatment of tobacco addiction. The
benefits of this study outweigh the small risks associated with participating
in the study.
Burgemeester Oudlaan 50
Rotterdam 3062PA
NL
Burgemeester Oudlaan 50
Rotterdam 3062PA
NL
Listed location countries
Age
Inclusion criteria
Age 25-55 years
Smoking at least 10 filter cigarettes per day
Smoking for at least 10 years
Fagerstrom Test for Nicotine Dependence score of at least 3
Primarily smoking filter cigarettes and nog any other form of tobacco
Desire to quit smoking
Having at least one quit attempt using an evidence-based treatment
Exclusion criteria
Previous experience with TMS
Primarily smoking tobacco products other than filter cigarettes, such as shag,
cigars, e-cigarettes and cannabis
Currently undergoing other treatment to quit smoking
Current diagnosis or last year treatment for a psychiatric disorder
Suffering from a neurological disorder
Heavy use or possible dependence on alcohol
Heavy use or possible dependence on substances other than tobacco
TMS and MRI contraindications, including:
o Cardiac demand pacemakers, implanted defibrillators, or other electronic
implants.
o History of seizure or heat convulsion.
o History of epilepsy or seizure in first degree relatives; Receiving or
requiring antiepileptic drugs.
o History of head injury.
o History of metal implants in the head (except dental fillings).
o Known history of any metallic particles in the eye, implanted cardiac
pacemakers or any intracardiac lines, implanted neurostimulators, surgical
clips or any medical pumps.
o Hearing loss or history of hearing loss.
o Known history of cochlear implants
o Known or possible pregnancy
o Systemic and metabolic disorders.
o Any known factor that lowers the threshold for epileptic seizures (e.g.
psychotropic medications, sleep deprivation, caffeine, substance abuse, etc.).
o Irremovable prosthesis.
o Irremovable piercings.
o Irremovable medicine patches
o IUDs placed within 6 weeks or material other than copper.
o Irremovable dentures.
o Implanted lenses in the eye.
o Bone screws or plates.
o Metal particles in the eye or they body.
o Tinnitus
o Inadequate communication with the patient
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 | NL86870.018.24 |