To examine the protective effects of a single session of high frequency rTMS over the left dorsolateral prefrontal cortex on negative mood and motivated attention.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the effect of rTMS and sham rTMS on mood as measured with
changes in visual analogue scales and PANAS before and after negative mood
induction.
Secondary outcome
To investigate the effect of rTMS and sham rTMS on motivated attention for sad
and facial expressions after sad mood induction.
Background summary
In spite of a wide variety of treatment options, the prognosis of major
depression is still poor: chronicity affects at least a third of patients and
relapses are common. Optimisation of existing treatment strategies are urgently
needed.Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral
prefrontal cortex (DLPFC) has been introduced more than a decade ago as an
antidepressive treatment option, but its acute effects on mood and cognitive
functioning remain unclear. Furthermore, it remains unknown whether rTMS can
have neuroprotective effects that prevents relapse during remission.By inducing
an electric current in the TMS coil, a magnetic field is created leading to the
induction of a secondary electric current in the stimulated brain area (for an
extended description see, Schutter, 2011)
. Depending on the frequency by which a magnetic pulse is emitted, a
stimulation or inhibition on a neuronal level is induced (Siebner & Rothwell,
2003), which effects can last longer than the stimulation itself, if applied
over an extended period of time (Hallett, 2007). In this way, high frequency
(10Hz or faster) stimulation lasting several minutes can enhance the
excitability of the stimulated area for a prolonged period of time (Fitzgerald
et al., 2006; Schutter, 2009) therefore likely to change not only mood but also
attentional biases that are thought to play a causal role in onset and
maintenance of depression. While clinical research is ongoing, testing more
standardized forms of rTMS treatment in a randomized controlled trial set-up,
more fundamental knowledge is also needed to investigate the potential
neuroprotective effects of rTMS. May it be useful in the future to weaken the
effects of external factors by influencing mood resilience in subjects.
Study objective
To examine the protective effects of a single session of high frequency rTMS
over the left dorsolateral prefrontal cortex on negative mood and motivated
attention.
Study design
In the present sham-controlled crossover study a single session of active and
sham high frequency rTMS will be applied to the left dorsolateral prefrontal
cortex in healthy volunteers. A validated sad mood induction procedure will be
applied after rTMS to measure its mood protective effects. Furthermore, the
effects on motivated attention and resting state electric brain activity (EEG)
will be assessed.
Intervention
All 24 participants will experience the rTMS treatment. Once real rTMS and once
sham-rTMS, both will take 30 minutes. The two intervention sessions will be
separated by at least 1 week with a maximum of four weeks.
Study burden and risks
All measurements will be administered during two visits of 2 hrs at our
outpatient depression unit. The actual rTMS treatment will take about 30
minutes. Except for financial compensation or course credit points, possible
benefit resulting from the treatment cannot be guaranteed to participants.
Transcranial magnetic stimulation (TMS) is a widely used non-invasive brain
stimulation technique, based on the principle of electromagnetic induction.
During stimulation the participant will likely hear the clicks of the TMS
pulses and experience stimulation of nerves and muscles of the head. The most
common side effect is a light transient headache (2-4% occurrence). A severe
headache is uncommon (0.3-0.5% occurrence). In the current study healthy
participants will be stimulated with a protocol that falls within the safety
guidelines. All participants are screened for their relevant medical history
and other TMS safety aspects (e.g. presence of metal parts in the head). There
are no risk factors related to the computerized attention training. There is no
direct benefit for the participants. The study will broaden our understanding
of how rTMS influences mood and cognition that may have clinical implications.
Reinier Postlaan 10
Nijmegen 6525 EX
NL
Reinier Postlaan 10
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
24 healthy, right-handed women using oral contraceptives and men (aged 18-35) with normal or corrected-to-normal vision
Exclusion criteria
* Epilepsy, convulsion or seizure (TMS)
* Serious head trauma or brain surgery
* Large or ferromagnetic metal parts in the head (except for a dental wire)
* Implanted cardiac pacemaker or neurostimulator
* Pregnancy
* History or current presence of any neurologic or psychiatric disease
* Any prescribed medication that can alter cortical excitability (e.g. antiepileptics, tricyclic anti-depressives or benzodiazepines) or can have an influence on the participant*s vigilance or cognitive performance within two weeks prior to participation
* Color blind
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 | NL50753.091.14 |