Empathy Clinical Trial
Official title:
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Impulsivity and Empathy in a Non-clinical Population
Impulsivity describes the tendency to make risky and unplanned decisions, to pick immediate reward over a bigger reward after a period of time or to not be able to resist the urge to do something. Empathy refers to the ability to be sensitive to and vicariously experience other people's feelings and to create working models of emotional states. Recent neuroscientific research have found that the right frontal part of the brain (left dorsal lateral frontal cortex, LDLPFC) is important in the control of impulsive behaviour and empathy. Self-report questionnaires have been proven valid measures at assessing impulsivity and empathy. Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive brain stimulation procedure; stimulation can be applied at different brain regions depending on the administration method. It temporally changes the way that this part of the brain functions, providing us a further understanding of how this part works. Recent research has found that rTMS on the LDLPFC changes performance-based tasks measuring different types of impulsivity and empathy. This study aims to investigate this further to look at the RDLPFC stimulation and its effects on empathy and two different types of impulsivity. Of interest is also how innate impulsive personality type and empathy trait relate to performance on these tasks.
Background Impulsivity describes the tendency to make risky and unplanned decisions, to pick
immediate reward over a bigger reward after a period or to not be able to resist the urge to
do something. Empathy refers to the ability to be sensitive to and vicariously experience
other people's feelings and to create working models of emotional states. Recent
neuroscientific research have found that the left frontal part of the brain (left dorsal
lateral frontal cortex, RDLPFC) is important in the control of impulsive behaviour and
empathy. Self-report questionnaires have been proven valid measures at assessing impulsivity
and empathy. Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used
non-invasive brain stimulation procedure; stimulation can be applied at different brain
regions depending on the administration method. It temporally changes the way that this part
of the brain functions, providing us a further understanding of how this part works. Recent
research has found that rTMS on the LDLPFC changes performance based tasks measuring
different types of impulsivity and empathy. This study aims to investigate this further to
look at the LDLPFC stimulation using the newer form of high-frequency rTMS, intermittent
theta burst stimulation (iTBS) and its effects on empathy and two different types of
impulsivity. Of interest is also how innate impulsive personality type and empathy trait
relate to performance on these tasks.
Aims The specific purposes of this study are to (i) examine whether iTBS is an effective
technique for modulating impulsivity and empathy, and to (ii) examine the relationship
between the modulatory effects of the iTBS and baseline self-reported impulsivity and
empathy.
The key objectives of this study are to examine whether the specific iTBS protocol at RDLPFC
can effectively modulate two subtypes of impulsivity (delayed discounting and reflection
impulsivity) and empathy, and to examine whether the participant's baseline self-reported
impulsivity and empathy scores mediate the modulatory effects of the iTBS on impulsivity and
empathy respectively in normal healthy young adults. The secondary objectives of this study
are to examine whether the self-reported measures of impulsivity and empathy correlate with
their performance-based counterparts.
Experimental protocol and methods The proposed study will be a single-centre, crossover
design study, taking place at Queens Medical Centre, Nottinghamshire NHS Trust. Participants
(male students or staff) will be recruited from the University of Nottingham. A potential
participant will be asked to complete the TMS screening questionnaire to ensure that there
are no contraindications to using TMS. After the written informed consent is obtained, he
will then be asked to complete an online questionnaire (Barratt Impulsiveness Scale -version
11, BIS-11) measuring self-report impulsivity. The scores obtained from BIS-11 will be one of
the screening criteria. If the potential participant is eligible for taking part in the
study, he will be invited to the two laboratory sessions. He will then be asked to perform
three computerised tasks assessing impulsivity and empathy before and after the iTBS
administration. Each session of iTBS will apply 600 pulses to the LDLPFC, with 20 2-second
trains and an 8-second inter-train interval for a total stimulation time of 190 seconds. Sham
iTBS condition will be administered with the same methodology used for active iTBS condition
with a sham coil mimicking noises and vibrations without delivery of magnetic pulses.
Participants will be asked to guess which rTMS condition is real after completing the whole
study to ascertain that whether the sham manipulation is successful or not. Participants will
be monitored if they experience any adverse events during the rTMS session and instructed to
report any experience of adverse events after each rTMS session. Tolerability will be
presented as the number of reported adverse events and the number of dropouts due to adverse
events.
Measurable end points/statistical power of the study To detect the change in impulsivity and
empathy resulted from the iTBS intervention, G*Power 3.1.9.2 was used to estimate sample size
required in consideration of interaction effect (impulsivity group × iTBS conditions) of
repeated measure ANOVA. The following parameters were selected: effect size f = 0.20
(equivalent to d = 0.40, estimated from the results of previous meta-analyses), alpha error
probability = .05, power = (1- β error probability) = .80, number of groups = 2, number of
measurements = 2 and correlation among repeated measurements = 0.6. A minimum of total sample
size of 42 subjects will be required. Considering the dropout rate of 0.20 (according to
previous rTMS studies), 54 subjects will be required for the study, including 27 high
impulsivity participants and 27 low impulsivity participants.
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