The primary objective of the proposed study is to test the practical feasibility and tolerability of real-time fMRI neurofeedback training of amygdala signal in military personnel and veterans with impulsive aggression. The secondary objective of…
ID
Source
Brief title
Condition
- Impulse control disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of the proposed study are (i) the tolerability of the
training procedure, as measured by a short self-report questionnaire, (ii) the
degree to which self-regulation training is successful, measured by statistical
analysis of the amygdala signal during feedback runs, and (iii) transfer of the
training effects, measured by statistical analysis of the amygdala signal
during transfer runs.
Secondary outcome
The secundary study parameters of the proposed study are (i) the extent to
which the neurofeedback procedure reduces symptoms related to impulsive
aggression, as measured by five self-report questionnaries, and (ii) the extent
to which functional connectivity between the amygdala and prefrontal cortex is
increased as a result of the training procedure, as measured by functional
connectivity analysis.
Background summary
Problems with impulsive aggression are common in the military and veteran
population, and are linked to a heightened amygdala response to emotional
facial stimuli. Real-time fMRI neurofeedback is a training method in which
participants learn to self-regulate the (re)activity of their amygdala, and
holds the promise of a potential and effective new treatment strategy for
military impulsive aggression.
Study objective
The primary objective of the proposed study is to test the practical
feasibility and tolerability of real-time fMRI neurofeedback training of
amygdala signal in military personnel and veterans with impulsive aggression.
The secondary objective of the proposed study is to test the potential
therapeutic efficacy and neural effects of the training procedure.
Study design
The proposed study concerns a feasibility pilot with an uncontrolled open-label
design.
Intervention
Participants are asked to self-regulate their amygdala signal, as represented
by a thermometer, in response to pictures of human faces that change from a
neutral expression to an angry one. A transfer run will additionally be added
wherein participants are asked to self-regulate their amygdala response to the
same dynamic face stimuli, only in the absence of feedback information.
Study burden and risks
Participants will undergo two sessions of real-time fMRI neurofeedback training
of amygdala signal (± 40 min, each), separated by (±) one week; a resting-state
scan will additionally be administered on the first, but not the second, visit
(± 9 min). Self-report questionnaires on anger (BPAQ), aggression (STAXI-2),
anxiety (STAI), impulsiveness (BIS-11), and depressive symptoms (BDI-II) will
be administered before (first visit) and after (second visit) the main training
procedure (± 30 min, each). A short screening list on traumatic brain injury
will additionally be administered on the first but not the second visit. The
risks (i.e., discomfort) and costs (i.e., time, effort) of participation are
considered minimal relative to the potential benefits (i.e., possible
therapeutic effects, overall interest in the experiment).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Dutch military personnel or veterans
- Age 18-60
- The presence of impulsive aggression problems according to the criteria as described by Coccaro (2012)
- Provide written informed consent
Exclusion criteria
- Alcohol or drug abuse and/or dependence
- A history of neurological disorders (e.g., Parkinson*s disease, CVA, multiple sclerosis)
- Claustrophobia
- The presence of a pacemaker or other metallic implant that might interfere with MRI acquisition
Design
Recruitment
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 | NL64377.041.18 |